drugset / Trial / NCT04133623

Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma

NCT04133623

Phase 3 Completed 212 enrolled IRCCS Burlo Garofolo
RandomizedParallel-groupTriple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ibuprofen Small molecule 10 mg/kg Oral
Subject Ketorolac Other / unclassified 0.5 mg/kg Oral

Indications

No indication recorded.