Severe pain + 2mg of Morphine = severe pain.

- Rogue Medic

Drug shortages leading to better EMS protocols

-

MIEMSS (Maryland Institute for Emergency Medical Services Systems) has posted some changes to their protocols that are in response to the drug shortages affecting EMS.

This is good news, even though two of the three drugs being used as replacements are also subject to drug shortages. That is one of the problems with the drug shortage – the replacements end up suffering from increased demand to replace the original drugs.

Some of the drugs do not need any replacement, such as IV (IntraVenous) furosemide (Lasix) for CHF/ADHF (Congestive Heart Failure/Acute Decompensated Heart Failure) patients. The best thing we can do is to stop giving the drug and to stop giving any other diuretic for a medical condition that is not effectively treated with diuretics.[1]

Pain management drugs are important and availability is important.
 

The continuing medication shortage continues to affect Maryland EMS Operational Programs (EMSOPs). Morphine is among the medications that EMSOPs have had difficulty restocking.

Because of the importance of successfully managing pain in out-of-hospital medicine, the Protocol Review Committee has looked into alternatives to Morphine for Maryland EMS. MIEMSS has emergently included fentanyl in the 2012 Maryland Medical Protocols effective immediately. Please see the attached protocol pages.[2]

 

Unfortunately, the obvious substitutes are also in short supply – fentanyl (Sublimaze), hydromorphone (Dilaudid), and other opioids.[3]

One interesting part of the Maryland protocols is the addition of abdominal pain to their standing orders for morphine or fentanyl administration. The Maryland protocols have leapfrogged past Pennsylvania’s protocols with a couple of big changes.
 


Image credit.

Even a surgical journal has research showing that treating undifferentiated abdominal pain with opioids does not make diagnosis more difficult.
 

CONCLUSION:
The literature addressing early pain relief for abdominal pain is characterized by weaknesses, but there is a common theme suggesting that analgesia is safe. Pending further research, which should address some of the shortcomings of extant studies, a practice of judicious provision of analgesia appears safe, reasonable and in the best interests of patients in pain.
[4]

 

A much more recent Cochrane Review comes to the same conclusion.

MAIN RESULTS:
Eight studies fulfilled the inclusion criteria. Differences with use of opioid analgesia were verified in variables: Change in the intensity of the pain, change in the patients comfort level.

AUTHORS’ CONCLUSIONS:
The use of opioid analgesics in the therapeutic diagnosis of patients with AAP does not increase the risk of diagnosis error or the risk of error in making decisions regarding treatment.
[5]

 

If we were to ask the patients what they prefer, I expect that a lot would choose to decrease their pain, even if there is the minimal possibility of alteration in physical assessment. That alteration may be for the better – if the patient is not in severe pain at the slightest touch, the patient may be able to localize the pain, which is a big part of the physical assessment of undifferentiated abdominal pain.

-

Footnotes:

-

[1] Drug Shortages Affect Those Still in the Dark Ages – Furosemide
Rogue Medic
Thu, 26 Aug 2010
Article

-

[2] NEW (June 2012) – Emergency Medication Addition Due to Medication Shortage: FENTANYL
Maryland Institute for Emergency Medical Services Systems
June 12, 2012
MIEMSS page with links to this and other updates and to current protocols

There is also information at that page about the following two changes because of the drug shortage –

NEW (April 2012) – Emergency Medication Addition Due to Medication Shortage: KETAMINE

NEW (May 2012) – Emergency Medication Addition Due to Medication Shortage: DIAZEPAM

-

[3] Current Drug Shortages Index
FDA
Current Drug Shortages Index

-

[4] Effect on diagnostic efficiency of analgesia for undifferentiated abdominal pain.
Thomas SH, Silen W.
Br J Surg. 2003 Jan;90(1):5-9. Review.
PMID: 12520567 [PubMed - indexed for MEDLINE]

-

[5] Analgesia in patients with acute abdominal pain.
Manterola C, Vial M, Moraga J, Astudillo P.
Cochrane Database Syst Rev. 2011 Jan 19;(1):CD005660. Review.
PMID: 21249672 [PubMed - indexed for MEDLINE]

.

These authors read far too much into their limited study – Part II

ResearchBlogging.org
-

Continuing from Part I.

The authors do not find dramatic differences between fentanyl and morphine in their ability to relieve pain in patients who are not hypotensive. In the discussion, they begin to give their reasons for not wanting to use fentanyl.

Why?

I don’t know why they are not fond of fentanyl, but this is what they write in their discussion.

Our study opens the door for debate regarding the value of including fentanyl in limited formularies such as medical helicopters and ambulances given its higher cost and lack of any detectable advantages when compared to morphine. Whereas at our institution fentanyl costs approximately the same as morphine, costs may vary widely in other institutions.[1]

The authors state that their cost is about the same for morphine and for fentanyl, but they think that the possibility that someone somewhere might be paying a lot more for fentanyl is reason enough to limit their choices to morphine.

Both drugs are available as generics, so there does not appear to be any reason to bring a hypothetical difference in price into the discussion. Both generic drugs are affected by the current drug shortages.

If we are much more concerned about giving morphine to hypotensive patients, than we are about giving fentanyl to hypotensive patients, is that worth a bit of a premium in the price of fentanyl?

I think so. More on fentanyl and hypotensive patients in a little bit.

There is also the question of whether including fentanyl in prehospital formularies is worth the risk given its abuse potential among medical staff. Although surveillance data suggest that nationally, fentanyl is one of the least abused drugs in the non-physician population, fentanyl abuse by physicians is a well-recognized concern (24,25).[1]

The first reference does not even mention fentanyl abuse. the second reference appears to be there as a reference for the lack of abuse by non-physicians.

There is no reference for the statement that fentanyl abuse by physicians is a well-recognized concern.

Is fentanyl more of a concern than morphine?

Is fentanyl less of a concern than morphine?

There is nothing in this paper to answer that question. Are the authors using a traditional doctors’ tale an old wives’ tale?

It looks that way.

-

There was no detectable difference with the limited number of patients, the limited dosing of medication, and the refusal to include patients with a blood pressure that was not at least 10 points above where hypotension begins.

Patients were excluded if they reported an allergy to morphine or fentanyl, or if they were hypotensive before receiving the first dose of the study drug (systolic blood pressure < 100 mm Hg).[1]

It isn’t as if they would have been giving large doses.

It isn’t as if there is a significant concern that fentanyl will cause hypotension.

Fentanyl appears to be one of our most effective treatments for getting rid of hypotension.

There was a 47% chance that a hypotensive patient would no longer be hypotensive after a dose of fentanyl.

-

the safety of fentanyl as demonstrated in the current study may be related to more conservative dosing in unstable patients, but the parallel message is that experienced EMS crews are able to exercise judgment in determining which patients should receive cautious drug dosing.[2]

Should we assume that there is no judgment going into the dosing of patients?
 

experienced EMS crews are able to exercise judgment in determining which patients should receive cautious drug dosing.
 

-

When should we expect hypotension after giving a dose of fentanyl?

When the patient is already hypotensive.

I have written more about this study.[3]
 

The study is not a bad idea, since the information on the lack of hypotensive effect of fentanyl[2] was not yet published. However, the conclusions are not justified by the results of this study.

The conclusions may best be described as imaginative.

The authors seem to be experiencing a case of the vapors and might want to consider taking some anti-anxiety medication.

According to the available research, which is much more extensive than this study, fentanyl is very safe, even when the patient is hypotensive.

There is less evidence to demonstrate that the morphine is safe for treating hypotensive patients with pain, but that does not appear to be a concern of the authors, even though the pain of hypotensive patients should be the concern of all of us who treat hypotensive patients.

Is fentanyl expensive?

No.

Is fentanyl effective?

Yes.

Is fentanyl dangerous?

Fentanyl is one of the safest drugs we use.

The ignorance of those on the pushing end of the fentanyl syringe is what is dangerous.

The problem is not the fentanyl, but the ignorance.

-

Footnotes:

-

[1] The Effectiveness and Adverse Events of Morphine versus Fentanyl on a Physician-staffed Helicopter.
Smith MD, Wang Y, Cudnik M, Smith DA, Pakiela J, Emerman CL.
J Emerg Med. 2012 Jul;43(1):69-75.
PMID: 21689900 [PubMed - in process]

There is one unusual aspect to the study that does not appear to affect the outcome, but raises questions about how many obstacles to research we create, when the obstacles may not be valid.

The study was fully reviewed by our Institutional Review Board, and given that both treatment arms are considered acceptable practice with equal risk, informed consent was not deemed necessary for this study. Upon completion of participation, each patient was given a verbal and written debriefing of his or her study involvement.[1]

-

[2] Fentanyl in the out-of-hospital setting: variables associated with hypotension and hypoxemia.
Krauss WC, Shah S, Shah S, Thomas SH.
J Emerg Med. 2011 Feb;40(2):182-7. Epub 2009 Mar 27.
PMID: 19327928 [PubMed - in process]

Full Text PDF Download at medicalscg.

-

[3] Fentanyl in the out-of-hospital setting: variables associated with hypotension and hypoxemia
Rogue Medic
Fri, 27 May 2011
Article

Chart Version – Fentanyl in the out-of-hospital setting: variables associated with hypotension and hypoxemia
Rogue Medic
Sun, 05 Jun 2011
Article

Safety of prehospital intravenous fentanyl for adult trauma patients
Rogue Medic
Thu, 03 May 2012
Article

-

Smith MD, Wang Y, Cudnik M, Smith DA, Pakiela J, & Emerman CL (2012). The Effectiveness and Adverse Events of Morphine versus Fentanyl on a Physician-staffed Helicopter. The Journal of emergency medicine, 43 (1), 69-75 PMID: 21689900

-

Krauss WC, Shah S, Shah S, & Thomas SH (2011). Fentanyl in the out-of-hospital setting: variables associated with hypotension and hypoxemia. The Journal of emergency medicine, 40 (2), 182-7 PMID: 19327928

.

These authors read far too much into their limited study – Part I

ResearchBlogging.org
-

There is a new study that looks at prehospital fentanyl. It starts out well, it is even randomized, blinded, and prospective, but it loses focus and draws conclusions that are not remotely justified by the study. Starting out well -

In one study looking at patients transported to EDs by ambulance with painful extremity injuries, patients who did not receive analgesics during transport waited approximately 75 min after arrival to the hospital before receiving any analgesic medication (2).[1]

This is a real problem.

Does prehospital fentanyl decrease that delay, or in other ways improve outcomes?

-

The authors cite several possible benefits – takes effect more quickly, is metabolized more quickly, causes less nausea, and causes less hypotension. However, they seem to ignore the last one – less likely to produce hypotension. In prehospital treatment, this is important.

-

They do not have many scene transports (only 16%) and they have doctors on the helicopters, so the authors’ flight service appears to take a conservative approach to treatment. On the other hand, their study protocol makes me look like Scrooge.

Each milliliter of study drug contained either 4 mg of morphine or 50 mg of fentanyl. The dosing was kept below the recommended loading doses of each narcotic to aid in blinding and allow for repeat dosing in small aliquots in the concentrations available in our pharmacy.[1]

However, that non sequitur plan appears to have worked even worse than we would expect.

Why not start out with a double dose?

The dose of morphine used in many studies is 1.0 mg/kg followed by doses of 0.05 mg/kg.

The repetition of the dose every 5 minutes should have made this not a problem, but the study protocol had a ridiculous limitation.

Each patient was allowed a maximum of five doses of the study drug.[1]

That is a maximum of 20 mg morphine or 250 µg fentanyl.

Depending on the weight of the patient, I can give more morphine or fentanyl on standing orders than these doctors can. If I reach my standing orders maximum, I can call medical command for orders to give more.

The authors even acknowledge this in their discussion.

Our initial doses correspond to 0.05 mg/kg of morphine and 0.71 mg/kg of fentanyl for a 70-kg adult, whereas others have found that sufficient pain relief required doses of 1.0 mg/kg and 1.6 mg/kg, respectively (7,20).[1]

What is the point of arbitrarily limiting the total dose?

The point certainly does not have anything to do with good patient care, since there is no evidence that any such arbitrary limit in any way improves outcomes.

If anyone knows of any research to suggest that this limitation improves outcomes, please provide it, but I do not know of any justification for this limit.
 


 

An average (mean) of 3 doses of morphine and 3.3 doses of fentanyl. That is 12 mg morphine and 165 µg fentanyl. These are not large doses, but the results show that they only had very limited success in managing pain.

Although they could start treating at a pain level of 1 out of 10, they still stopped at 5 out of ten – a pain level that would be appropriate for me to start treating with morphine or fentanyl, or to continue treating with morphine or fentanyl. I treat moderate to severe pain.

But it gets worse.

Of patients in the study, 57.5% received analgesics before being enrolled, without a significant difference between either arm. Although the medication name was recorded, the dose was not always recorded by the flight crew. Average doses of morphine, Dilaudid, and fentanyl were 4 mg, 1 mg, and 100 mg, respectively, and were similar in both arms, based on available data.[1]

Most of these patients had already received an average of one dose of study drug (or the equivalent amount of hydromorphone [Dilaudid]) prior to being entered in the study, so the pain management should have just been a continuation of treatment, even though the dose they already received had been inappropriately low for a starting dose.

-

Patients who reported any pain score other than zero were then given the study drug in a 1-mL intravenous bolus. Patients were then reassessed every 5 min (normal flight protocol, with automated monitor and clinical evaluation) during transport with a complete set of vital signs (including pulse oximetry) and another numeric pain score. During each reassessment, a 1-mL bolus of the study drug was given for any pain score > zero.[1]

Except that does not appear to be even close to what happened.

Although the study protocol called for administration of medication every 5 min, a mean of only three doses was given despite a mean patient care time of 40 min.[1]

-

A change of 13 mm on the visual analog scale and a corresponding change of 1.3 on the NPS have been generally accepted as a clinically significant change in pain relief (8,12,13). We found that both morphine and fentanyl at repeated study doses provided clinically significant pain relief by decreases in mean pain scores of 2.2 and 2.5, respectively.[1]

Yes, the difference was clinically significant, but we can do much better. Here are the details of the pain levels -

The mean pain score at the beginning of enrollment was 8.0 ± 2.0 in the morphine arm and 8.0 ± 1.8 in the fentanyl arm. The mean final pain score was 5.8 ± 2.7 in the morphine arm and 5.5 ± 2.4 in the fentanyl arm. The median initial pain score was 8, with an IQR of 3. There was no difference between the two groups. The median final pain score was 5, with an IQR of 3.5, with no significant difference between the two groups (Table 2).[1]

Starting morphine pain level from 6 to 10 out of 10.   Starting fentanyl pain level from 6.2 to 9.8 out of 10.

Ending morphine pain level from 3.1 to 8.5 out of 10.   Ending fentanyl pain level from 3.1 to 7.9 out of 10.
 


 

This is not even cutting the pain in half – this is only cutting the pain a little.

that is still important, but it could be much better.

61.5% of morphine patients and 69% of fentanyl patients had a significant improvement in pain level (≥2 according to their predefined criteria).

There were no incidences of pruritis or vomiting in either group. There were no episodes of hypotension in either group.[1]

-

To be continued in Part II.

-

Footnotes:

-

[1] The Effectiveness and Adverse Events of Morphine versus Fentanyl on a Physician-staffed Helicopter.
Smith MD, Wang Y, Cudnik M, Smith DA, Pakiela J, Emerman CL.
J Emerg Med. 2012 Jul;43(1):69-75.
PMID: 21689900 [PubMed - in process]

There is one unusual aspect to the study that does not appear to affect the outcome, but raises questions about how many obstacles to research we create, when the obstacles may not be valid.

The study was fully reviewed by our Institutional Review Board, and given that both treatment arms are considered acceptable practice with equal risk, informed consent was not deemed necessary for this study. Upon completion of participation, each patient was given a verbal and written debriefing of his or her study involvement.[1]

-

Smith MD, Wang Y, Cudnik M, Smith DA, Pakiela J, & Emerman CL (2012). The Effectiveness and Adverse Events of Morphine versus Fentanyl on a Physician-staffed Helicopter. The Journal of emergency medicine, 43 (1), 69-75 PMID: 21689900

.

Safety of prehospital intravenous fentanyl for adult trauma patients

ResearchBlogging.org

What prevents us from treating pain appropriately?

Actual adverse effects of pain medicine or unwarranted anxiety, due to exaggerated fears of potential adverse effects of pain medicine?

-

In 1999, the Emergency Medical Services Outcomes Project identified prehospital pain relief as a priority outcome and noted that it is one of the most high-impact prehospital interventions that can be performed on the majority of patients.3 [1]

Pain management is important. Unfortunately, EMS and emergency medicine have been better at coming up with excuses for not treating pain, than we have been at coming up with good protocols that encourage treating pain.

-

Our hypothesis was that a single dose of intravenous fentanyl administered in the prehospital setting would have no detrimental effect on the shock index of initially normotensive adult trauma patients.[1]

If we appropriately assess our patients, give reasonable doses of fentanyl (or any other pain medicine), is there any good reason to expect that there will be any harm to patients?

If we cannot appropriately assess our patients, what kind of incompetence justifies authorizing us to work as paramedics?

-

The protocol change allowed paramedics to administer a single 100 µg dose of fentanyl to adult trauma patients being transported “Code 10” (e.g., lights and sirens) to the hospital without a call to the medical command center. No other opioid was allowed for pain management in this population. Before the protocol change, medical command approval was required before administration of fentanyl.[1]

I see this as even more evidence that medical command permission requirements have nothing to do with protecting patients.

When medical command permission was required, pain management was rare.

-

-

After the protocol change patients were almost 6 times more likely to receive fentanyl.

 

The harm of medical command permission requirements is not controlled for, nor is it a hypothesis of the study. If this does reflect the way that medical command permission requirements discourage, or prevent, appropriate patient care, that raises a question –

 

How can we justify continuing to allow our patients to be harmed by medical command permission requirements?

 


Image credit.

-

Inclusion criteria were (1) age ≥ 18 years; (2) systolic blood pressure (SBP) >90 mm Hg; (3) Glasgow Coma Scale (GCS) score ≥13; and (4) emergent trauma transport to Denver Health Medical Center. Emergent trauma was defined as any “Code 10″ (e.g., lights and sirens) transport to the hospital. Exclusion criteria were pregnancy and imprisonment.[1]

Pain is not listed as an inclusion criterion.

Severe pain? Moderate pain and severe pain? Abdominal pain? What is permitted on standing orders?

-

The outcome was the initial ED shock index (defined as the heart rate divided by SBP). As pain relief from fentanyl would typically result in a decrease in both heart rate and blood pressure, the shock index was chosen as a composite outcome for its ability to reflect, as a single dependent variable in a multivariable model, abnormal changes in heart
rate and blood pressure.
[1]

This may be a better way to assess vital sign changes than just looking at blood pressure, but is this part of what is used during anesthesia or procedural sedation to assess vital signs?

What if the patient is hypotensive before fentanyl, then receives fentanyl? What if some pain relief produces the expected decrease in heart rate, but the same pain relief also produces an increase in blood pressure?

This study’s protocol would not permit giving fentanyl to hypotensive patients, but that study has already been done –

-


Click on images to make them larger.[2] [3]

-

In 47% of cases of administration of fentanyl to already hypotensive trauma patients, the hypotension went away after fentanyl.

Why aren’t we doing larger studies of giving fentanyl to hypotensive patients?

Why are we withholding fentanyl from hypotensive patients?

What if . . . ?

What if we behave intelligently and actually find out?

Perpetuating myths and traditions is bad for patients.

We need to stop the defenders of tradition and mythology from harming our patients.

-

-

There is a 97% chance that, after administration of fentanyl to a critical trauma patient who is not hypotensive, the patient will still be not hypotensive.

There is a 47% chance that, after administration of fentanyl to a critical trauma patient who is hypotensive, the patient will be not hypotensive.

If we did not have so much anxiety about fentanyl, we might consider making it the standard of care for hypotension following trauma.

A total of 1,669 patients met criteria for inclusion during the study period.[1]

This is one of the problems with not fully describing the criteria. Did all of these patients have pain that met the criteria for administration of fentanyl? If so, then giving fentanyl to only 217 patients (13% of 1,699) is horrible.

-

Seven patients had an initial ED SBP <90 mm Hg, and all were included in the control group.[1]

Would fentanyl have prevented those cases of hypotension?

-

Footnotes:

-

[1] Safety of prehospital intravenous fentanyl for adult trauma patients.
Soriya GC, McVaney KE, Liao MM, Haukoos JS, Byyny RL, Gravitz C, Colwell CB.
J Trauma Acute Care Surg. 2012 Mar;72(3):755-759.
PMID: 22491566 [PubMed - as supplied by publisher]

-

[2] Fentanyl in the out-of-hospital setting: variables associated with hypotension and hypoxemia.
Krauss WC, Shah S, Shah S, Thomas SH.
J Emerg Med. 2011 Feb;40(2):182-7. Epub 2009 Mar 27.
PMID: 19327928 [PubMed - in process]

Full Text PDF Download at medicalscg.

Fentanyl Study: EMS Research Episode 9
EMS Research Podcast
Podcast page

-

[3] Chart Version – Fentanyl in the out-of-hospital setting: variables associated with hypotension and hypoxemia
Sun, 05 Jun 2011
Rogue Medic
Article

-

Soriya GC, McVaney KE, Liao MM, Haukoos JS, Byyny RL, Gravitz C, & Colwell CB (2012). Safety of prehospital intravenous fentanyl for adult trauma patients. The journal of trauma and acute care surgery, 72 (3), 755-759 PMID: 22491566

.

Is It Possible To Be Alert And Oriented With 10/10 Pain – Part II

-

Continuing from Part I. Unfortunately, with my protocols, an altered level of consciousness prohibits me from giving opioid pain medication on standing orders for burns or for musculoskeletal trauma.

-

-

d. Patient has altered level of consciousness [1]

Isn’t the problem the severity of the pain?

If I have pain that is truly 10 out of 10, is it possible for me to NOT have an altered level of consciousness?

For example, if I were using a wood chipper and had an arm dragged into the blades before I could hit the safety bar (the orange rail around the opening), I would not expect to be able to provide reasonable answers to any of the level of consciousness questions we routinely ask.

-


Image credit.

-

What is my name?

Maybe I can get that one right.

Where am I?

I’m stuck in a chipper. There might be some superfluous adjectives included in my response, but is that question really appropriate at this time?

Do I know what day it is today?

Could today be the day I engage in a bit of justifiable homicide? I ordinarily look at my cell phone to find out the date. My hand appears to be occupied, so I may not have easy access to my phone – assuming that I even want to answer the question.

We do want to know about allergies and medical conditions, but the only reason to ask level of consciousness questions is a misguided effort to treat the protocol at the expense of the patient.

Are there any signs of a head injury? That would be much more useful information than Alert and Oriented Times Three.

The truth of severe pain is that level of consciousness improves AFTER several doses of pain medicine.

We should expect level of consciousness and vital signs to improve after treatment with high doses of medications that would be expected to worsen level of consciousness and vital signs in people who do not have severe pain.

Pain medicine can be morphine, fentanyl, hydromorphone (Dilaudid, Palladone), or other opioid medication. Another possibility to help in extricating me from the wood chipper, that is less likely to produce respiratory depression, is ketamine.

-

Imagine that extreme amount of pain, the pain continuing at about the same level, then having to reverse the wood chipper to get my arm out.

Do you imagine that there would be a normal level of consciousness on my part?

Is that an acceptable reason to deny me treatment?

Is that an acceptable reason to deny me treatment that will probably improve my level of consciousness?

Suppose that I had severe burns, rather than musculoskeletal trauma. Would the concern about level of consciousness be any different?

-

-

What do you think?

-

Footnotes:

-

[1] Musculoskeletal Trauma 6003 and Burns 6071
Pennsylvania Statewide Advanced Life Support Protocols
7007 – ALS – Adult/Peds
Page 73/128 and Page 80/128
Free Full Text PDF of All ALS Protocols

.

Is It Possible To Be Alert And Oriented With 10/10 Pain – Part I

 

Unfortunately, with my protocols, an altered level of consciousness prohibits me from giving opioid pain medication on standing orders for burns or for musculoskeletal trauma.
 


 

I can call command for permission to treat the patient, just as I can call for permission to treat abdominal pain or other exclusions from my standing orders. My patient does have to wait for me to go through the Mother May I? ceremony of ignorance. This requirement encourages medical directors to authorize incompetent paramedics and distracts paramedics from patient assessment, but it appeals to the insecurities of the hands-off medical directors.

As if appropriately treating pain aggressively is dangerous.
 


Image credit.
 

What do you think?

If this is your arm, is pain medicine a bad idea?

Let’s look at the exclusions –
 

a. Oxygen saturation ≤ 95% [1]

 

Give supplemental oxygen and give the pain medicine. Unfortunately, waiting for the sat to rise may cause the patient more pain. We should be raising the patient’s sat to 95% anyway, but the low sat may help to decrease alertness and awareness of pain a little bit.

Is hypoxia really a problem when giving fentanyl?
 

Assessment of the 522 administrations in 279 non-intubated patients revealed no difference in the mean SpO 2 readings before (98.8%, 95% CI 98.5–98.9) and after (98.6%, 95% CI 98.3–99.0) fentanyl administration. There were no instances of hypoxemia in these non-intubated patients receiving fentanyl (one-sided 97.5% CI for 0/279: 0–1.3%). [2]

 

No cases of hypoxia caused by fentanyl, even though these patients were given large doses. The average total dose was 3.0 μ/kg.

3.0 μ/kg is the maximum total dose available on standing orders in my protocols, but 3.0 μ/kg was just the average total dose for these patients who never experienced any hypoxia.
 

b. SBP < 100 for adults

c. SBP < 70 + 2(age in years) for children < 14 y/o [1]

 

Is hypotension really a problem when giving morphine?

Sometimes.

Is hypotension really a problem when giving fentanyl?
 

of 2129 patients receiving an opioid (fentanyl), only 12 (0.6%) had a medication-related vital sign abnormality and an intervention was required only once (in a patient who had no sequelae)(8) [3]

 

Overall, in 45 cases (4.3% of 1055), fentanyl was administered to patients who were hypotensive. [2]

 

Oh, no!

They’re all going to die!
 

In 53% of these cases, hypotension (predictably) remained after the opioid was given—but in 47% of cases in which fentanyl was administered to hypotensive patients, the next SBP exceeded 90. [2]

 

Inconceivable!

Is hypotension really a problem when giving fentanyl?

No.

There is no good reason to avoid giving fentanyl for severe pain with hypotension.

 

The best thing to do for hypotension may be to give fentanyl.

 
 

d. Patient has altered level of consciousness [1]

 

This will be the topic in Part II.

-

Footnotes:

-

[1] Musculoskeletal Trauma 6003 and Burns 6071
Pennsylvania Statewide Advanced Life Support Protocols
7007 – ALS – Adult/Peds
Page 73/128 and Page 80/128
Free Full Text PDF of All ALS Protocols

For people working in EMS in Pennsylvania, there is a FREE app that includes BLS protocols and ALS protocols from the University of Pittsburgh Medical Center. Rather than have to go through all of the protocols to find the right one, this allows for very quick searching of individual protocols and for the use of other features. I have found this to be very handy for checking the specifics of a protocol I have not looked at in a while. Please, let me know if there are other similar apps out there.
FREE Android app page.
FREE iPhone app page.

-

[2] Fentanyl in the out-of-hospital setting: variables associated with hypotension and hypoxemia.
Krauss WC, Shah S, Shah S, Thomas SH.
J Emerg Med. 2011 Feb;40(2):182-7. Epub 2009 Mar 27.
PMID: 19327928 [PubMed - in process]

Full Text PDF Download at medicalscg.

-

[3] Safety and effectiveness of fentanyl administration for prehospital pain management.
Kanowitz A, Dunn TM, Kanowitz EM, Dunn WW, Vanbuskirk K.
Prehosp Emerg Care. 2006 Jan-Mar;10(1):1-7.
PMID: 16418084 [PubMed - indexed for MEDLINE]

Free Full Text PDF Download from MSTC.

.

Community and International All in One – EMS Garage Episode 150 and Fentanyl

-

This week’s EMS Garage covered several topics. Community and International All in One: EMS Garage Episode 150. Chris Montera, Gary Wingrove, Pat Songer, Russell Stine, and I discuss these topics –

International Roundtable of Community Paramedics and Community Paramedic – Community Paramedic is something that is inevitable. Many people do not like the idea, but there is no practical alternative. The main question is how to best set up a Community Paramedic program.

-

International Paramedic – We need to stop using the infantile excuse of That’s not the way we do it here. This attitude kills patients. Imagine if everyone decided that they would freeze their thinking at some point in time and never make any progress beyond that point unless it came from their own people. That is the opposition to International Paramedic. We need to recognize that we have a lot to learn from the way the rest of the world implements EMS. We need to stop ignoring what others are doing and start learning from others. Go sign up at International Paramedic.

-


Image credit.

-

Ultrasound in EMS“Machines made by Sono-Site Inc. will be put on 12 ambulances. The company provided the devices, which cost $60,000 to $70,000 each, and about $52,000 in training, Knapp said.” According to Pat Songer, his service is using different devices that only cost $6,000 to $6,700 each – less than 10% of the cost listed in the article. They have a lot of support from the hospital, which is very important. This has a lot of potential to improve care. We need to pay attention to the research and see what the advantages and disadvantages are. I am hesitant to suggest that this be used to encourage refusals, but triaging patients to community hospitals seems to be an area where this cuts costs and improves care.

-

Legal Medicine – We assume that we know how not to be sued or how not to lose a law suit, but this is just another EMS myth.

-

And fentanyl

A little bit on fentanyl. I mentioned that the most important advantage in using fentanyl is that it wears off quickly. This means that a patient who receives enough fentanyl to tolerate an ambulance ride (a bouncy truck ride lying on top of the rear axle as it hits pot holes) should already have the fentanyl wearing off when we arrive at the ED (Emergency Department). Time from administration and total dose will affect how quickly it wears off.

Why is fentanyl wearing off quickly important?

If the patient has enough fentanyl on board to tolerate the ambulance ride, then lying in a much better padded hospital bed that does not bounce around may result in oversedation and the main complication we wish to avoid – respiratory depression. In the ED they can assign one nurse to take care of this patient until the patient is breathing more deeply or they can give naloxone (Narcan).

Unfortunately, in some EDs they will quickly whip out the naloxone and will not titrate it to the desired effect – adequate respirations. A standard dose of naloxone can result in complete reversal of the pain management and increase the pain to much more than it was when we began treating the pain. Not titrating naloxone results in reversal of all of the endorphin effects – all the things that a person is able to do on their own to manage their pain.

Not titrating naloxone is torture.

-


Image credit. Ouch! Don’t be stingy with the fentanyl.

-

We want to avoid putting the patient in the situation of having their pain relief reversed. In the ED, one on one observation of patients is not common. The patient is being transferred from EMS, which has several people observing the patient, to the ED, which has several patients per nurse. The ED is just not staffed to provide one on one observation without detracting from the care of other patients. Sometimes staff will over-react to respiratory depression and hurt the patient.

We should not be causing problems for the ED or for the patient by transferring a patient that the ED is not as prepared to treat than we are in EMS.

Not noticing dangerous respiratory depression in EMS is incompetence.

Not noticing dangerous respiratory depression in the ED may be just due to having divide attention among many patients at a time when things change.

-

Go listen to all of these at EMS Garage.

.

Fentanyl in the out-of-hospital setting: variables associated with hypotension and hypoxemia

-ResearchBlogging.org

-

Also posted over at Paramedicine 101 (now at EMS Blogs) and at Research Blogging. Go check out the rest of the excellent material at these sites.

-

On the most recent episode of the EMS Research Podcast,[1] Harry Mueller, Bill Toon, and I discuss a recently published paper examining what effect prehospital fentanyl has on hypoxemia or on hypotension.

-

This study’s objectives were to assess for association between prehospital fentanyl administration and the occurrence of either of the following: hypotension, defined as a drop in systolic blood pressure (SBP) to below 90 mm Hg in a patient at least 5 years of age, or hypoxemia, defined as a drop in peripheral oxygen saturation (SpO2) to below 90%.[2]

-

There were 500 patients and many of them received more than one dose of fentanyl. Several received 6 separate doses of fentanyl.

-

Even with so many doses given, the mean dose and maximum dose were not that high.[3]

The median dose of fentanyl per administration was 1.1 µg/kg (IQR 0.8–1.4; range 0.25–3.5 µg); the mean dose was 1.1 µg/kg (SD 0.46). Expressed as a total dose per patient (i.e., summing all doses in a given patient), the median dose was 2.5 µg/kg (IQR 1.7–3.9) with a mean of 3.0 µg/kg (SD 1.8).[2]

1.1 µg/kg per dose.

The maximum single dose is unusual and is not explained. range 0.25–3.5 µg which should be /kg.

How did one patient receive such a large single dose – 3.5 µg/kg? The thing that makes the most sense (if this was a dosing error) is that this was a small pediatric patient. I carry fentanyl in syringes that contain 100 µg in 2 ml (50 µg/ml), but they might carry vials that have a larger volume. for example, below is packaging for 250 µg in 5 ml (also 50 µg/ml). If an entire vial were given to a 140 kg patient, that would be a dose of 3.5 µg/kg.

Is that what happened?

I don’t know – and that is presuming that this is a dosing error, which may not be valid to presume.


Image credit.[4]

I like the idea of carrying 10 mg morphine syringes and 100 µg fentanyl syringes. The total dose of each syringe is roughly equivalent in its effect on a patient. Except in very unusual circumstances, even a full 10 mg morphine, or 100 µg fentanyl, is not going to produce significant problems – and that is assuming that there is no judgment going into the dosing of patients.

Should we assume that there is no judgment going into the dosing of patients?

No, but I will get back to this in a little bit.

If this was not a dosing error, it is extremely aggressive dosing. I am comfortable giving a bit more than 1 µg to otherwise healthy trauma patients or burn patients, but I will at least give this a couple of minutes to have some kind of effect and reassess the patient before giving more. Similarly, with morphine, I might give up to 0.15 mg/kg to these same patients. 3.5 µg/kg is about three times higher than I am comfortable with.

Does that make the dose inappropriate?

Without knowing the specifics, we really cannot tell.

-

Should we assume that there is no judgment going into the dosing of patients?

There are prior data to support the safety of appropriately administered opioids, including fentanyl. The study of Kanowitz et al., although more methodologically rigorous than most reports, is typical in its demonstration of safety: of 2129 patients receiving an opioid (fentanyl), only 12 (0.6%) had a medication-related vital sign abnormality and an intervention was required only once (in a patient who had no sequelae)(8) [2]

-

What about in this study?

It is noteworthy that, although the study HEMS program’s fentanyl protocol does not proscribe use of the drug in hypotensive patients, the crew are required to use the agent judiciously (in other words, at the lower end of the recommended dosage range). This means that the safety of fentanyl as demonstrated in the current study may be related to more conservative dosing in unstable patients, but the parallel message is that experienced EMS crews are able to exercise judgment in determining which patients should receive cautious drug dosing.[2]

Should we assume that there is no judgment going into the dosing of patients?

experienced EMS crews are able to exercise judgment in determining which patients should receive cautious drug dosing.

The authors of this study do not come to the conclusion that EMS crews cannot make dosing decisions independently. The authors come to exactly the opposite conclusion.

-

What about the hypotension and hypoxemia?

New hypotension (i.e., post-fentanyl SBP < 90 in a patient at least 5 years of age, with pre-fentanyl SBP at least 90) was seen in 28 administrations (2.7% of 1055 administrations, 95% CI 1.8–3.8%).[2]

Vital signs were measured within ten minutes of each dose of fentanyl (usually within 5 minutes).

Does hypotension developing so soon after fentanyl mean that the fentanyl caused the hypotension?

No.

It is possible that fentanyl did cause the hypotension.

It is possible that fentanyl did contribute to a drop in the blood pressure.

It is possible that fentanyl did not affect the blood pressure at all.

It is possible that fentanyl had the effect of increasing the blood pressure, but that increase was outweighed by something else causing a greater drop in blood pressure.

We do not have enough information to determine what effect fentanyl has on blood pressure in these patients, but we no longer have a good reason for expecting that fentanyl will produce hypotension.

There are many possible side effects of fentanyl, but even in hypotensive patients we should not expect any sudden deterioration in blood pressure with judicious administration of fentanyl by competent EMS personnel.

The authors do make one error here. They use the total number of administrations of fentanyl in their calculation of the rate of new hypotension to come up with 2.7%.

Overall, in 45 cases (4.3% of 1055), fentanyl was administered to patients who were hypotensive.[2]

Those 45 patients should be excluded from the calculation of new hypotension. Therefore the rate should be 2.8%, rather than 2.7%. This does not change the conclusions in any way. This is just a technicality.

What about those 45 patients who were hypotensive before receiving fentanyl?

In 53% of these cases, hypotension (predictably) remained after the opioid was given—but in 47% of cases in which fentanyl was administered to hypotensive patients, the next SBP exceeded 90.[2]

About half of the patients who were hypotensive before fentanyl were not hypotensive after fentanyl.

While 45 is a small number of hypotensive patients, how many of us would like to have a treatment for hypotension that is effective on half of our patients?

I am only partly kidding.

We do not know what other treatments were being provided, but how many of these patients may have had changes to their vital signs due to severe pain?

We presume that fentanyl will make vital signs worse, but that is a mistake. We may make less of a mistake with worrying that morphine will cause hypotension, based its potential for histamine release.

What was the effect of fentanyl on vital sign abnormalities in the Kanowitz study of fentanyl?

Of the 2,315 patients who received fentanyl in the field, 66 patients had a vital sign abnormality. Of those 66 patients, three were excluded because they received a sedative in addition to the fentanyl. There were 46 patients who were excluded because their vital sign abnormalities occurred before the administration of fentanyl. Of the 46 patients who had a vital sign abnormality before the administration of fentanyl, 38 patients’ vital signs improved after the administration of fentanyl, eight patients’ vital signs remained the same, and none worsened.[5]

Of the 46 patients who had a vital sign abnormality before the administration of fentanyl, 38 patients’ vital signs improved after the administration of fentanyl, eight patients’ vital signs remained the same, and none worsened.

It is possible that fentanyl is improving vital signs by decreasing pain.

The problem is that so many of us do not take the pain of others seriously, so we do not expect pain to lead to problems with vital signs.

Does the improvement in vital signs so soon after fentanyl mean that the fentanyl caused the improvement in vital signs?

No.

It is possible that fentanyl did cause the improvement in vital signs.

It is possible that fentanyl did contribute to an improvement in vital signs.

It is possible that fentanyl did not affect the vital signs at all.

It is possible that fentanyl had the effect of worsening the vital signs, but that worsening was outweighed by something else causing a greater improvement in vital signs.

We do not have enough information to determine what effect fentanyl has on vital signs in these patients, but we no longer have a good reason for expecting that fentanyl will frequently produce bad vital signs. Fentanyl was much more likely to be followed by an improvement in vital signs.

-

We almost forgot about hypoxemia. Hypoxemia is an even bigger concern than hypotension.

What effect did fentanyl have on hypoxemia?

Assessment of the 522 administrations in 279 non-intubated patients revealed no difference in the mean SpO 2 readings before (98.8%, 95% CI 98.5–98.9) and after (98.6%, 95% CI 98.3–99.0) fentanyl administration. There were no instances of hypoxemia in these non-intubated patients receiving fentanyl (one-sided 97.5% CI for 0/279: 0–1.3%).[2]

Not even a single instance of hypoxemia.

None.

This was such a big concern that one of the helicopter services near me (based in a university hospital) only permitted flight crews to give fentanyl after a patient was intubated.

No tube – no fentanyl.

Myth busted.

We do need to be cautious about the administration of fentanyl to any patient. We should continually monitor ECG, SpO2, blood pressure, respiratory drive, and level of consciousness. With higher doses we should also continuously monitor waveform capnography.

Fentanyl is safe in the hands of competent EMS providers.

Fentanyl should not require medical command contact for any dose.

-

Go listen to the podcast.

Contact EMS Research at:
603-397-0367
emsresearchcast at gmail dot com
EMSResearchCast on Twitter
EMS Research at FaceBook

-

Footnotes:

-

[1] Fentanyl Study: EMS Research Episode 9
EMS Research Podcast
Podcast

-

[2] Fentanyl in the out-of-hospital setting: variables associated with hypotension and hypoxemia.
Krauss WC, Shah S, Shah S, Thomas SH.
J Emerg Med. 2011 Feb;40(2):182-7. Epub 2009 Mar 27.
PMID: 19327928 [PubMed - in process]

Full Text PDF Download at medicalscg.

-

[3] Mean, Median, Mode, and Range
Purplemath
Article

It is good to be clear on what the meaning of the terminology. This has the simplest explanation I found in a very brief search.

The “mean” is the “average” you’re used to, where you add up all the numbers and then divide by the number of numbers. The “median” is the “middle” value in the list of numbers. To find the median, your numbers have to be listed in numerical order, so you may have to rewrite your list first.

-

[4] FENTANYL CITRATE injection, solution
[Baxter Healthcare Corporation]

FDA Label
DailyMed
How Supplied
Free Full Text FDA Label from DailyMed with links to Free Full Text PDF Download.

-

[5] Safety and effectiveness of fentanyl administration for prehospital pain management.
Kanowitz A, Dunn TM, Kanowitz EM, Dunn WW, Vanbuskirk K.
Prehosp Emerg Care. 2006 Jan-Mar;10(1):1-7.
PMID: 16418084 [PubMed - indexed for MEDLINE]

Free Full Text PDF Download from MSTC.

-

Krauss, W., Shah, S., Shah, S., & Thomas, S. (2011). Fentanyl in the Out-of-Hospital Setting: Variables Associated with Hypotension and Hypoxemia The Journal of Emergency Medicine, 40 (2), 182-187 DOI: 10.1016/j.jemermed.2009.02.009

Kanowitz A, Dunn TM, Kanowitz EM, Dunn WW, & Vanbuskirk K (2006). Safety and effectiveness of fentanyl administration for prehospital pain management. Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors, 10 (1), 1-7 PMID: 16418084

.