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

This study is to compare ibuprofen and ketorolac for children with trauma-related acute pain. 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 h. 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 min until 2 h after drug and placebo administration. The primary outcome was NRS-11 reduction at 60 min. Among 125 patients with severe pain, 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). Ibuprofen was significantly better, considering secondary outcomes, at 90 min 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 min 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. Trial registration: ClinicalTrial.gov registration number: NCT04133623. What is Known: • Limb trauma is one of the most common causes of paediatric emergency department visits. Non-steroidal anti-inflammatory drugs are the most frequently used analgesics in this clinical setting. In particular ibuprofen is the first over the counter non-steroidal anti-inflammatory drug in terms of use. Ketorolac is considered the most effective non-steroidal anti-inflammatory drug for severe pain. What is New: • This study directly compared oral ibuprofen and ketorolac for moderate and severe acute traumatic pain in children and adolescents. Both drugs were similarly effective in children and adolescents with severe pain, and ketorolac was not superior to Ibuprofen for moderate pain. [ABSTRACT FROM AUTHOR]