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Oral Analgesics Utilization for Children With Musculoskeletal Injury (OUCH Trial): An RCT
Sylvie Le May1,2, Samina Ali3,4, Amy C Plint5,6
1Faculties of Nursing and sylvie.lemay@umontreal.ca.
Insights
A combination of morphine and ibuprofen did not effectively manage pain in children with musculoskeletal injuries in the emergency department. Most children did not achieve adequate pain relief with any of the tested medications.
Area of Science:
- Pediatric Emergency Medicine
- Pain Management
- Pharmacology
Background:
- Musculoskeletal injuries (MSK-Is) are common and painful in children, often inadequately treated in emergency departments (EDs).
- Effective pain management strategies for pediatric MSK-Is in the ED are crucial.
Purpose of the Study:
- To evaluate the efficacy of combining an anti-inflammatory drug (ibuprofen) with an opioid (morphine) for pediatric musculoskeletal injury pain in the ED.
- To compare the effectiveness of morphine plus ibuprofen, morphine alone, and ibuprofen alone in reducing pain.
Main Methods:
- A randomized, double-blinded, placebo-controlled trial involving children (6-17 years) with MSK-I and high pain scores (VAS >29 mm).
- Participants received either oral morphine + ibuprofen, morphine + placebo, or ibuprofen + placebo.
- The primary outcome was achieving a visual analog scale (VAS) pain score below 30 mm at 60 minutes post-administration.
Main Results:
- Out of 456 participants in primary analyses, pain relief targets were not significantly different across groups (29.9% morphine+ibuprofen, 29.3% morphine, 33.0% ibuprofen).
- Mean VAS pain reduction at 60 minutes was comparable across all groups.
- The combination and morphine-only groups reported significantly more side effects than the ibuprofen-only group, with no serious adverse events.
Conclusions:
- Combining morphine with ibuprofen did not offer superior pain relief for pediatric MSK-Is in the ED.
- Current study medications were insufficient for optimal pain management, as most children did not reach a mild pain score.
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).
