Acetaminophen (Paracetamol) or Opioid Analgesia Added to Ibuprofen for Children's Musculoskeletal Injury: Two Randomized Clinical Trials
Abstract
Importance
Ibuprofen is first-line therapy for musculoskeletal pain. However, two-thirds of children experience inadequate pain relief with ibuprofen monotherapy, and the efficacy of additive medications for moderate to severe musculoskeletal pain is unclear.
Objective
To determine whether treatment with an opioid (hydromorphone) plus ibuprofen or nonopioid (acetaminophen [paracetamol]) plus ibuprofen decreased pain scores compared with ibuprofen alone.
Design, Setting, and Participants
Two randomized, double-masked, placebo-controlled trials were conducted from April 2019 to March 2023 in 6 university-affiliated, tertiary care Canadian pediatric emergency departments. Children aged 6 to 17 years presenting with a nonoperative acute limb injury (<24 hours) and a verbal numerical rating scale (vNRS) pain score of 5 or more out of 10 were enrolled. Date of final follow-up was March 22, 2023.
Interventions
The opioid trial randomized participants to a single oral dose of ibuprofen plus hydromorphone, ibuprofen plus acetaminophen, or ibuprofen alone. The nonopioid trial randomized participants to a single oral dose of ibuprofen plus acetaminophen or ibuprofen alone. In all groups, ibuprofen was dosed at 10 mg/kg (maximum, 600 mg). The acetaminophen dose was 15 mg/kg (maximum, 1000 mg), and the hydromorphone dose was 0.05 mg/kg (maximum, 5 mg).
Main Outcomes and Measures
The primary efficacy outcome was self-reported vNRS pain score at 60 minutes post medication administration…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 8,098 participants or records.
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