NCT04133623: Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From…

Summary

Pain is the leading cause of access to the paediatric emergency department (ED) and present in up to 78% of cases. Acute osteoarticular traumatic pain is often treated inadequately, and there is little data about the best treatment for children. The ibuprofen and ketorolac are respectively the most used and one of the most powerful NSAIDs. In literature, there is no direct comparison between those two medications. The objective of the study depends on the level of pain: * in severe traumatic acute pain (\>=7 points): to evaluate if ketorolac is superior to ibuprofen in the treatment of pain (n=130 children, 65 allocated to ketorolac and 65 to ibuprofen) * in moderate traumatic acute pain (\<7 points): to evaluate if ibuprofen is not inferior to ketorolac in the treatment of pain (n=120 children, 60 allocated to ketorolac and 60 to ibuprofen)

Timeline

Start: 2019-11-19
Primary completion: 2021-09-30
Completion: 2021-09-30

Outcome

Missed primary endpoint

paper NRS-11 reduction after 60 min from drug administration was 2.0 (IQR 1.0-4.0) for ibuprofen and 1.0 (IQR 1.0-3.0) for ketorolac (p = 0.36). PMID 36526794 ↗

paper the NRS-11 reduction after 60 min from drug administration was 1.63 (± 1.8) for ibuprofen and 1.8 (± 1.6) for ketorolac, with no statistically significant difference. PMID 36526794 ↗

Publications

Ghirardo S, Trevisan M, Ronfani L, Zanon D, Maestro A, Barbieri F, De Nardi L, Amaddeo A, Barbi E, Cozzi G. Oral ibuprofen versus oral ketorolac for children with moderate and severe acute traumatic pain: a randomized comparative study. Eur J Pediatr. 2023 Feb;182(2):929-935. doi: 10.1007/s00431-022-04759-3. Epub 2022 Dec 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ibuprofen	Small molecule	10 mg/kg	Oral
Subject	Ketorolac	Other / unclassified	0.5 mg/kg	Oral

Indications