Oral ibuprofen versus oral ketorolac for children with moderate and severe acute traumatic pain: a randomized comparative study

Abstract

Abstract Purpose: Compare ibuprofen and ketorolac for children with trauma-related acute pain. Methods: We conducted a multicentre randomized, double-blind, controlled trial in the Paediatric Emergency Department setting. We enrolled patients aged 8 to 17 who accessed the emergency department for pain related to a limb trauma that occurred in the previous 48 hours. At the admission, patients were classified based on numeric rating scale-11 (NRS-11) in moderate (NRS 4-6) and severe (NRS 7-10) pain groups. Each patient was randomized to receive either ibuprofen (10 mg/kg) or ketorolac (0.5 mg/kg) and the placebo of the not given drug in a double dummies design. NRS-11 was asked every 30 minutes until 2 hours after drug and placebo administration. The primary outcome was NRS-11 reduction at 60 minutes. Results: Among 125 patients with severe pain, NRS-11 reduction after 60 minutes 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). Ibuprofen was significantly better, considering secondary outcomes, at 90 minutes with a lower median of NRS-11 (p 0.008), more patients with NRS-11 less than 4 (p 0.01) and a reduction of pain score of more than 3 NRS-11 points (p 0.01). Among 87 patients with moderate pain, the NRS-11 reduction after 60 minutes from drug administration was 1.63 (±1.8) for ibuprofen and 1.8 (±1.6) for ketorolac, with no statistically significant difference. Conclusions: Oral ibuprofen and ketorolac are similarly effective in children and adolescents with acute traumatic musculoskeletal pain. ClinicalTrial.gov registration number: NCT04133623