Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children (NCT07145645)
Topical Diclofenac vs. Oral Ibuprofen for Musculoskeletal Pain in Children: A Multi-centre, Randomized Pilot Feasibility Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (14 items).
Location: Alberta Children's Hospital — Calgary, Alberta
Age range: 6 Years to 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Previous enrolment in the trial
- Barriers to topical treatment application, including skin conditions (e.g. eczema, infection, open wounds) or overlying material (e.g., rigid cast) which would make applying topical treatment impossible.
- Any other history, condition, therapy, or uncontrolled intercurrent illness, which could, in the opinion of the Qualified Medical Investigator or treating physician, would make the participant unsuitable for this study
- Any contraindication to NSAID use including but not limited to a history of GI bleeding, gastric ulcer, inflammatory bowel disease, prior cerebrovascular bleeding, bleeding diathesis, interstitial kidney disease
- Taking NSAIDs daily for other indications (e.g, chronic pain or arthritis)
- Known hypersensitivity to ibuprofen, diclofenac or other NSAIDs.
- Any known allergy or intolerance to any components or trace constituents (e.g., aloe vera, tree nuts or corn) of the investigational products
- Current use of prohibited medications known to impair renal function when combined with NSAIDs or cause potential additive risks of gastrointestinal toxicity and renal impairment
- Absence of a parent/guardian for children who are not mature minors.
- Caregiver and/or child cognitive impairment precluding the ability to complete study procedures
- Inability to obtain consent, and to complete follow-up surveys due to language barrier
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- Alberta Children's Hospital — Calgary, Alberta
- Stollery Children's Hospital — Edmonton, Alberta
📞 Contact the Study Coordinator
Phone: (403) 955-7723
Email: mmeltork@ucalgary.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.