Clinical Trial

Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children

Study acronym: TOP-MAP
Recruiting Phase 3
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Summary
The TOP-MAP pilot trial has multiple goals. The first goal of this pilot clinical trial is to find out if it will be possible to carry out a study at multiple pediatric emergency department sites (Peds ED) comparing Non-Steroidal Anti-Inflammatory (NSAID) gel applied to a new ankle or knee injury to NSAIDs taken by mouth in kids aged 6-18. The investigators want to determine if the gel works as well or better at reducing pain than NSAIDs given by mouth. Based on studies done on adults, the investigators know that NSAIDs that are applied directly to an injury work as well at relieving pain as NSAIDs that are taken by mouth. Another goal of this pilot trial is to determine if it is possible to recruit participants to the study, and if the participants complete the questionnaire and take the medications as prescribed on Day 1. The participants will be in the study for 14 days. Participants will be required to take the oral NSAID medication and to apply the topical NSAID gel 3 times a day for the first 3 days after their visit to the ED. The investigators will ask the participants to rate their pain on a scale of 0 (no pain) to 10 (worst pain ever) before and after they use the medicine. On day 7, the participants will rate their pain, and their activity level. On day 14 participants will do the same.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-20.
Status change: Not Yet Recruiting → Recruiting 2026-04-07
Trial Details
NCT Number NCT07145645
Lead Sponsor University of Calgary
Collaborators: Hamilton Health Sciences Corporation
Conditions Musculoskeletal Injury, Pediatrics, Sprain and Strain of Ankle, Sprain Knee, Strain Knee
Enrollment 60 participants
Start Date 2026-04-02
Primary Completion 2027-09-30 (estimated)
Study Completion 2028-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-13