Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children

NCT07145645 | Recruiting Phase 3 DMC

• 1 other identifier: TOPMAP-25-02-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  To determine the feasibility of conducting a large multi-centre non-inferiority trial. This will be evaluated with the use of descriptive statistics of the following three measurements: 1. The investigators aim to achieve a 50% consent rate from all eligible candidates approached to participate. 2. The investigators' goal is to have 80% of the consented and enrolled participants complete the Day 1 (first 24-hour survey) follow up survey. This will be measured by counting the number of completed Day 1 surveys out of all Day 1 surveys that are expected to be completed. 3. The third metric is to have 80% of the participants adhere to the dosing regimen in the first 24 hours after discharge from the ED. This will be measured by calculating the number of participants that administered all 3 doses of study medications in the first 24 hours.

  Will be evaluated at study end, 18 months.

Secondary Outcomes (1)

• Pain relief as measured on the verbal Numerical Rating scale.

  First 24 hours after ED discharge

Study Arms (2)

Active topical Diclofenac Diethylamine emulgel

EXPERIMENTAL

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.

Drug: Voltaren Topical Gel; Drug: ORA-Blend Oral Suspension

Active Ibuprofen suspension

ACTIVE COMPARATOR

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.

Drug: Ibuprofen Oral Suspension 100 mg/5mL; Drug: VersaPro Cream Base for Compounding

Interventions

Ibuprofen Oral Suspension 100 mg/5mL DRUG

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

Also known as: Children's Motrin, Ibuprofen Oral Suspension

Active Ibuprofen suspension

VersaPro Cream Base for Compounding DRUG

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.

Also known as: Versapro Gel

Active Ibuprofen suspension

ORA-Blend Oral Suspension DRUG

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

Active topical Diclofenac Diethylamine emulgel

Voltaren Topical Gel DRUG

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.

Also known as: diclofenac emulgel, diclofenac diethylamine

Active topical Diclofenac Diethylamine emulgel

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Willing and able to complete follow-up surveys as per study protocol

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University of Calgary: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (2)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

RECRUITING

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

NOT YET RECRUITING

Related Publications (2)

• ChildHealth BC. Children's Emergency Department Services. Vancouver, BC: Child Health BC,2020/07/20. (Acessed 2024-08-07, athttps://www.childhealthbc.ca/sites/default/files/20-07-01-ed-tiers-setting-the-stage-1819-data.pdf.)

  RESULT

• Wang C, Toigo S, Zutrauen S, McFaull SR, Thompson W. Injuries among Canadian children and youth: an analysis using the 2019 Canadian Health Survey on Children and Youth. Health Promot Chronic Dis Prev Can. 2023 Feb;43(2):98-102. doi: 10.24095/hpcdp.43.2.05.

  PMID: 36794826 RESULT

MeSH Terms

Conditions

Sprains and Strains; Knee Injuries

Interventions

diclofenac diethylamine

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leg Injuries

Study Officials

• Mohamed M Eltorki, MBChB, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed M Eltorki, MBChB, MSc

CONTACT

403-955-7723; mmeltork@ucalgary.ca

Angela C Wallace, BA

CONTACT

403-955-5451; angela.wallace@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The double-dummy design is used since the two medications (oral vs. topical) look very different. Participants will take both medications at each time point (one being active and one being placebo) to maintain masking of the participants. The oral medication and the topical medication are provided to the participants in identical packaging to maintain blinding. Only the pharmacists will know which group the participant is in. If there's a medical reason to find out (for example, if the participant has a rare or unexpected allergic reaction), the doctors can access that information immediately.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot study to determine the feasibility of a large, multi-centre, non-inferiority trial of topical vs oral NSAIDs for acute pediatric MSK injuries. Both study medications (topical and oral) will be administered simultaneously to maintain masking of participants and accuracy of pain assessments. Medication will be given three times daily for the first 72 hours, followed by as-needed dosing for a total of 14 days.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 28, 2025
• Study Start: April 2, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Requests to access data can be made 9 months after the publication, for 36 months following article publication.
• Access Criteria: Proposals to access the anonymized, deidentified data should be submitted to the Principal Investigator, Dr. Mohamed Eltorki (mmeltork@ucalgary.ca). Only those researchers who submit a methodologically sound proposal to use the data for a meta-analysis will be considered for access.

Locations

CA (2)