drugset / Trial / NCT01690780
Oral Morphine Versus Ibuprofen
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for the first 24 hours following discharge from the emergency department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in greater pain relief than ibuprofen.
Timeline
- Start
- 2012-09
- Primary completion
- 2014-02
- Completion
- 2014-02
Outcome
Missed primary endpoint
paper We found no significant differences in the change in pain scores between morphine and ibuprofen between groups at any of the 4 time points (p = 0.6). PMID 25349008 ↗
Publications
- Faught L, Elzagallaai AA, Tonial N, Ali S, Lepore N, Reardon J, Urquhart B, Ross C, Rieder MJ, Poonai N. Oral morphine pharmacokinetics in healthy children and the effect of genetic polymorphisms: An exploratory study. Paediatr Child Health. 2025 Oct 12;31(1):35-41. doi: 10.1093/pch/pxaf084. eCollection 2026 Feb.
- Poonai N, Bhullar G, Lin K, Papini A, Mainprize D, Howard J, Teefy J, Bale M, Langford C, Lim R, Stitt L, Rieder MJ, Ali S. Oral administration of morphine versus ibuprofen to manage postfracture pain in children: a randomized trial. CMAJ. 2014 Dec 9;186(18):1358-63. doi: 10.1503/cmaj.140907. Epub 2014 Oct 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ibuprofen | Small molecule | 10 mg/kg | Oral |
| Subject | Morphine | Other / unclassified | 0.5 mg/kg | Oral |
Indications
No indication recorded.