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OUCH Trial – Pain Management in Children

January 16, 2018

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Neither morphine+ibuprofen nor either drug alone + placebo improved pain to a minimal score at 1 hour in children with acute extremity pain.

Why does this matter?
Pain is often undertreated in children.  Opiates like morphine are associated with increased side effects.  Would a non-opiate or opiate/NSAID combination be more effective?

OUCH…keeps on hurting
This was a multifactorial RCT with 0.2mg/kg po morphine + 10mg/kg po ibuprofen or morphine 0.2 mg/kg po + placebo of ibuprofen or ibuprofen 10 mg/kg + placebo of morphine.  They enrolled 501 children age 6-17 years with acute musculoskeletal injury (60% sprains, 40% fractures), randomized into one of the above groups.  They found that only 30% total had a decrease in visual analog pain score to 30mm or less at 60 minutes, which was the primary outcome.  There was no statistical difference in either morphine+ibuprofen, morphine alone, or ibuprofen alone, with a mean reduction in pain score of only about 18mm for each treatment arm.  I wonder if giving oral agents was not adequate for these injuries or if they needed a higher oral morphine dose (recommended dose 0.2 – 0.5 mg/kg).  Also, the RCT we covered earlier this month using oral agents in adults found better pain relief by hour 2 than hour 1, so this trial may have assessed for the primary outcome too early.  In fact, there was a statistically significant improvement in pain at hour 2 but only in children who received ibuprofen.  There were also significant numbers lost to follow up at 60 minutes, so the analysis was done per protocol and not intention-to-treat.  I also wonder how accurately a 6 year old can rate pain on a 100mm visual analog scale, with 0 being no pain and 100 being the worst imaginable pain.  Abstraction is difficult for younger children. Finally, more children who received morphine experienced nausea and fatigue.  Personally, if there is an obvious deformity, I use IV morphine.  But this study shows that for most sprains, even fractures, oral ibuprofen may be as effective, if not more effective than oral morphine.

Oral Analgesics Utilization for Children With Musculoskeletal Injury (OUCH Trial): An RCT.  Pediatrics. 2017 Nov;140(5). pii: e20170186. doi: 10.1542/peds.2017-0186. Epub 2017 Oct 11.

Peer reviewed by Thomas Davis, MD.  

What are your thoughts?