Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children
Recruiting
Phase 3
Interventional Study
Musculoskeletal Injury
Pediatrics
Sprain and Strain of Ankle
Sprain Knee
Strain Knee
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 – 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- University of Calgary · Other
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About This Trial
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 we…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age 6 to 18 years old.
2. Injury less than or equal to 4 days old
3. Non-fractured MSK soft-tissue injury (ankle or knee, confirmed clinically and/or radiographically)
4. Pain score of more than or equal to 3 on the verbal numerical rating scale, with movement in the past 2 h…
Contacts