Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-18
SponsorUniversity of Calgary
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 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.
Eligibility criteria
Qualifiers
Age 6 to 18 years old.
Injury less than or equal to 4 days old
Non-fractured MSK soft-tissue injury (ankle or knee, confirmed clinically and/or radiographically)
Pain score of more than or equal to 3 on the verbal numerical rating scale, with movement in the past 2 hours or before analgesia
Disqualifiers
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
Trial design
Treatments tested in this trial
- Voltaren Topical Gel
- Ibuprofen Oral Suspension 100 mg/5mL
- ORA-Blend Oral Suspension
- VersaPro Cream Base for Compounding
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Calgary
Lead sponsor
Hamilton Health Sciences Corporation
Collaborator
Source ClinicalTrials.gov