Recruiting
Phase 3

NSAID Gel & Oral NSAID

Sponsor:

University of Calgary

Code:

NCT07145645

Conditions

Musculoskeletal Injury

Pediatrics

Sprain and Strain of Ankle

Sprain Knee

Strain Knee

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Interventions

Voltaren Topical Gel

Ibuprofen Oral Suspension 100 mg/5mL

ORA-Blend Oral Suspension

VersaPro Cream Base for Compounding

Study Details

Brief summary:

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

Musculoskeletal Injury

Pediatrics

Sprain and Strain of Ankle

Sprain Knee

Strain Knee

Study ID

NCT07145645

Start date

Apr 2, 2026

Status verified date

Jul, 2025

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

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 hours or before analgesia
5. Willing and able to complete follow-up surveys as per study protocol

Exclusion Criteria:

1. Previous enrolment in the trial
2. 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.
3. 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
4. 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
5. Taking NSAIDs daily for other indications (e.g, chronic pain or arthritis)
6. Known hypersensitivity to ibuprofen, diclofenac or other NSAIDs.
7. Any known allergy or intolerance to any components or trace constituents (e.g., aloe vera, tree nuts or corn) of the investigational products
8. 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
9. Absence of a parent/guardian for children who are not mature minors.
10. Caregiver and/or child cognitive impairment precluding the ability to complete study procedures
11. Inability to obtain consent, and to complete follow-up surveys due to language barrier
12. Known or suspected late pregnancy (gestational age ≥20 weeks) at the time of enrolment or breastfeeding females, due to the risk of premature closure of the ductus arteriosus associated with NSAID use
13. Current enrollment in another pain-related clinical trial or in a study that, in the opinion of the Qualified Medical Investigator, may interfere with enrollment, involve investigational products that interact with study medications, or compromise follow-up and outcome assessment

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active topical Diclofenac Diethylamine emulgel

Topical Diclofenac emulgel is a topical NSAID with clinically proven analgesic, anti-inflammatory and antipyretic properties when applied directly to a soft tissue injury. NSAIDs reduce pain principally by inhibiting formation of prostaglandins, leukotrienes and free oxygen radicals. Diclofenac can be expected to produce a direct anti-inflammatory and analgesic effect to the area applied.

Participants randomized to the experimental arm will be given topical diclofenac gel (11.6 mg/g). Dosing is based on the following weight bands:

25 kg: 2 grams/dose;

≥25 kg - <40 kg: 3 grams/dose; and >40 kg: 4 grams/dose.

active comparator: Active Ibuprofen suspension

Active oral ibuprofen suspension. The ibuprofen suspension dose is 10 mg/kg to a maximum of 600 mg. Ibuprofen is commonly used in ED's as usual care for treatment of soft tissue injuries in pediatric patients.

Interventions

Voltaren Topical Gel

Topical diclofenac emulgel (Voltaren) 11.6 mg/g. Dosing is based on weight bands: 25 kg: 2 grams/dose, ≥25 kg - <40 kg: 3 grams/dose; and >40 kg: 4 grams/dose. ATC code: M02A A15.

Ibuprofen Oral Suspension 100 mg/5mL

Children's Ibuprofen Oral suspension (Motrin) 100mg/5 mL . Dosing is 10 mg/kg to a maximum of 600mg.

ORA-Blend Oral Suspension

Oral Ibuprofen suspension (labelled as ibuprofen) given at 10 mg/kg to a maximum of 600mg each dose.

VersaPro Cream Base for Compounding

Topical Versapro Cream emulgel (labeled as diclofenac diethylamine). Dose is based on the following weight bands: 25 kg: 2 grams/dose;

≥25 kg - <40 kg: 3 grams/dose; and >40 kg: 4 grams/dose.

Primary outcome measure

  • Feasibility of a large trial to be measured by the following: 1. 50% consent rate from all eligible candidates approached; 2. Achieve 80% completion rate of the first 24 hour survey, 3. Achieve 80% adherence rate to Day 1 dosing regimen. [ Time Frame: Will be evaluated at study end, 18 months. ]

Central Contacts and Locations

Central contacts

Mohamed M Eltorki, MBChB, MSc

403-955-7723mmeltork@ucalgary.ca

Locations

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Mohamed Principal Investigator

403-955-5373mmeltork@ucalgary.ca

Principal Investigator:

Mohamed Eltorki, MD, MBChB

More Information

Sponsor

University of Calgary

Last update posted

Apr 13, 2026

Last verified

Jul, 2025

Keywords

  • Non Steroidal Anti-Inflammatory
  • Pediatric Emergency Department
  • Pediatrics
  • Ankle or Knee Injury
  • Topical NSAIDs

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-04-13.