Actively Recruiting
Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children
Led by University of Calgary · Updated on 2026-04-13
60
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of Calgary
Lead Sponsor
H
Hamilton Health Sciences Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 to 18 years old
- Injury 4 days old or less
- Non-fractured musculoskeletal soft tissue injury to ankle or knee confirmed clinically or by imaging
- Pain score of 3 or higher on a verbal numeric scale with movement in past 2 hours or before pain medication
- Willing and able to complete follow-up surveys as required by the study
You will not qualify if you...
- Previous enrollment in this trial
- Skin conditions or wounds preventing topical treatment application
- Any other condition or illness making participation unsuitable as judged by medical staff
- Contraindications to NSAIDs including history of gastrointestinal bleeding, ulcers, inflammatory bowel disease, bleeding disorders, or kidney disease
- Daily NSAID use for other reasons such as chronic pain or arthritis
- Known allergy to ibuprofen, diclofenac, or other NSAIDs
- Allergy or intolerance to any ingredients in the study medications
- Current use of medications that increase risks when combined with NSAIDs
- No parent or guardian available for children who are not mature minors
- Cognitive impairment in child or caregiver preventing study participation
- Inability to consent or complete surveys due to language barrier
- Known or suspected pregnancy beyond 20 weeks gestation or breastfeeding
- Current enrollment in another pain-related clinical trial or conflicting study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
2
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Not Yet Recruiting
Research Team
M
Mohamed M Eltorki, MBChB, MSc
CONTACT
A
Angela C Wallace, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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