Topical Diclofenac vs. Oral Ibuprofen for Musculoskeletal Pain in Children: A Multi-centre, Randomized Pilot Feasibility Trial

What this Trial Is About

Researchers are evaluating pain management options for children aged 6 to 18 years who have suffered a recent ankle or knee soft tissue injury without fractures. This pilot clinical trial compares the effects of a topical Non-Steroidal Anti-Inflammatory Drug (NSAID) gel, specifically diclofenac emulgel, to oral NSAIDs, such as ibuprofen, in reducing pain. The study aims to assess whether the topical gel works as well or better than oral NSAIDs, and to determine if recruiting participants and collecting pain assessments is feasible in pediatric emergency departments. Participants will be randomly assigned to receive either topical diclofenac gel or oral ibuprofen suspension, both administered three times daily for the first three days after their emergency visit. The dosing of diclofenac gel is adjusted based on the child's weight, while ibuprofen is dosed at 10 mg/kg up to a maximum of 600 mg per dose. After the initial three days, dosing continues as needed for up to 14 days. The study is blinded and includes a double-dummy design to maintain masking of participants and staff. During the 14-day study period, participants will rate their pain on a scale from 0 (no pain) to 10 (worst pain ever) before and after medication use. Pain and activity level assessments are collected on days 1, 7, and 14. The primary outcome measures focus on the feasibility of conducting a larger trial, including consent rates, survey completion, and adherence to the dosing regimen. Researchers will also monitor pain relief and evaluate the acceptability of the treatments and data collection methods.

Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children