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Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children

Study acronym: TOP-MAP
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2, 2025 to Apr 2, 2026
    • Study sites: 0 to 2
    • Eligibility criteria expanded, about 11 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07145645
Lead Sponsor University of Calgary
Collaborators: Hamilton Health Sciences Corporation
Conditions
(from sponsor)
Musculoskeletal Injury, Pediatrics, Sprain and Strain of Ankle, Sprain Knee, Strain Knee
Related terms Knee Injuries, Sprains and Strains
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov