Friday, 30 January 2015

An RCT comparing intranasal fentanyl vs. ketamine… please stab me with a pitchfork

Sometimes you look at a study and think, “oh why…” But clearly the study authors of the PICHFORK trial and the editors of the Annals of Emergency Medicine think differently.

This was a double blind RCT comparing 1.5mcg of intranasal fentanyl to 1mg/kg of intranasal ketamine in children with limb injuries. The primary outcome was reduction in pain at 30 minutes.

With only 73 patients for analysis, there was no surprise that there was no statistical difference found in pain reduction. Obviously the possibility for a type II error is huge (i.e. not finding a difference when one was really present).

80% of the ketamine group had some adverse events that the authors conclude were minor. Who would have thought that something related to angel dust might cause some problems.

Those of us that have been using intranasal fentanyl know that it works very well and has been a game changer for paediatric analgesia. 1.5mcg/kg is at best a low starting dose and is usually repeated at 10 minutes. I personally usually give 2-3mcg/kg to start with depending on the situation.

By the way, the authors make a big point about the limitations of fentanyl in its 50mcg/ml concentration. But my ED has been using the 300mcg/ml concentration for years. It is made in Australia and widely available. (Oron Laboratories Pty Ltd, 25-29 Delawney St, Balcatta WA 6021 Australia)

My conclusion? This was an underpowered study that could only ever find large differences between the two treatment groups. Ketamine was compared to an inadequate or “straw-man” dose of fentanyl. Therefore there was no surprise that this study could not find any differences. It would be really disappointing if people are duped in to thinking this study is proof as to the effectiveness of intransal ketamine and subject children to undertreated pain and side effects. 

Ketamine certainly has its rightful place in Emergency Medicine. It is an absolutely fantastic drug for procedural sedation and for induction of RSI or DSI. But for primary analgesia, please use something that we know is safe, effective with minimal side effects. Stick with fentanyl.



Covering

Graudins A, Meek R, Egerton-Warburton D, et al. The PICHFORK (Pain in Children Fentanyl or Ketamine) Trial: A Randomized Controlled Trial Comparing Intranasal Ketamine and Fentanyl for the Relief of Moderate to Severe Pain in Children with Limb Injuries. Ann Emerg Med. 2014  Nov 18. pii: S0196-0644(14)01363-8. doi: 10.1016/j.annemergmed.2014.09.024. [Epub ahead of print]


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