NCT04133623

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

Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma: a Randomized Double-blind Controlled Study.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: IRCCS Burlo Garofolo · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Acute Pain Due to Trauma

Interventions

Type	Name	Description
DRUG	Ketorolac	Administration of ketorolac 0.5 mg/kg up to 10 mg, one single dose at the enrollment. This group will receive also a placebo indistinguishable from the ibuprofen.
DRUG	Ibuprofen	Administration of ibuprofen 10 mg/kg up to 600 mg, one single dose at the enrollment. This group will receive also a placebo indistinguishable from the ketorolac.

Timeline

• Start date: 2019-11-19
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2019-10-21
• Last updated: 2022-01-06

Locations

3 sites across 1 country: Italy