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Oral Analgesics Utilization for Children With Musculoskeletal Injury (OUCH Trial): An RCT. Pediatrics 2017 Nov;140(5)

Date

10/13/2017

Pubmed ID

29021235

DOI

10.1542/peds.2017-0186

Scopus ID

2-s2.0-85033555467   23 Citations

Abstract

BACKGROUND: Musculoskeletal injuries (MSK-Is) are a common and painful condition among children that remains poorly treated in the emergency department (ED). We aimed to test the efficacy of a combination of an anti-inflammatory drug with an opioid for pain management of MSK-I in children presenting to the ED.

METHODS: In this randomized, double-blinded, placebo-controlled trial, we enrolled children between 6 and 17 years presenting to the ED with an MSK-I and a pain score >29 mm on the visual analog scale (VAS). Participants were randomly assigned to oral morphine (0.2 mg/kg) + ibuprofen (10 mg/kg) (morphine + ibuprofen) or morphine (0.2 mg/kg) + placebo of ibuprofen or ibuprofen (10 mg/kg) + placebo of morphine. Primary outcome was children with VAS pain score <30 mm at 60 minutes postmedication administration.

RESULTS: A total of 501 participants were enrolled and 456 were included in primary analyses (morphine + ibuprofen = 177; morphine = 188; ibuprofen = 91). Only 29.9% (morphine + ibuprofen), 29.3% (morphine), and 33.0% (ibuprofen) of participants achieved the primary outcome (P = .81). Mean VAS pain reduction at 60 minutes were -18.7 (95% confidence interval [CI]: -21.9 to -16.6) (morphine + ibuprofen), -17.0 (95% CI: -20.0 to -13.9) (morphine), -18.6 (95% CI: -22.9 to -14.2) (ibuprofen) (P = .69). Children in the morphine + ibuprofen group (P < .001) and in the morphine group (P < .001) experienced more side effects than those in the ibuprofen group. No serious adverse event was reported.

CONCLUSIONS: Combination of morphine with ibuprofen did not provide adequate pain relief for children with MSK-I in the ED. None of the study medication provided an optimal pain management because most of children did not reach a mild pain score (NCT02064894).

Author List

Le May S, Ali S, Plint AC, M√Ęsse B, Neto G, Auclair MC, Drendel AL, Ballard A, Khadra C, Villeneuve E, Parent S, McGrath PJ, Leclair G, Gouin S, Pediatric Emergency Research Canada (PERC)

Author

Amy L. Drendel DO Professor in the Pediatrics department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Administration, Oral
Adolescent
Analgesics
Analgesics, Opioid
Anti-Inflammatory Agents, Non-Steroidal
Child
Double-Blind Method
Drug Therapy, Combination
Female
Humans
Ibuprofen
Male
Morphine
Musculoskeletal Diseases
Pain Management
Pain Measurement