Comparing Voltaren with Ibuprofen for musculoskeletal injury
Official title: Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children
Topical Diclofenac vs. Oral Ibuprofen for Musculoskeletal Pain in Children: A Multi-centre, Randomized Pilot Feasibility Trial
- Phase 3
- 2 groups
- Sites in Calgary and Edmonton
- Recruiting
Interventions (4)
- Medication
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.
- Medication
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.
- Medication
ORA-Blend Oral Suspension
Oral Ibuprofen suspension (labelled as ibuprofen) given at 10 mg/kg to a maximum of 600mg each dose.
- Medication
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.
Canadian Sites (2)
1 of 2 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta
- Not yet recruiting
Stollery Children's Hospital
Edmonton, Alberta
Eligibility Criteria
See who this study is looking for18 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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-upFollow-upContinued check-ins after the treatment part is finished.Read more → surveys as per study protocolProtocolThe detailed plan a study must follow.Read more →
Exclusion
- −Known or suspected late pregnancy (gestational age ≥20 weeks) at the time of enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → or breastfeeding females, due to the risk of premature closure of the ductus arteriosus associated with NSAID use
- −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
- −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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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)
- −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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →, and to complete follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → surveys due to language barrier
- −Current enrollment in another pain-related clinical trialInterventional studyA study where participants are given something to see what happens.Read more → 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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives one or more of: Voltaren Topical Gel and ORA-Blend Oral Suspension.
Registry label: A: Active topical Diclofenac Diethylamine emulgel
Group B, the comparison group, receives one or more of: Ibuprofen Oral Suspension 100 mg/5mL and VersaPro Cream Base for Compounding.
Registry label: B: Active Ibuprofen suspension
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 6 years to 18 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 60 people.
The study is currently expected to finish around March 2028.
The main measurement is taken over: Will be evaluated at study end, 18 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Feasibility of a large trial to be measured by the following: 1. 50% consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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 — measured over Will be evaluated at study end, 18 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07145645 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Voltaren Topical GelDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Ibuprofen Oral Suspension 100 mg/5mLDrug
Children's Ibuprofen Oral suspension (Motrin) 100mg/5 mL . Dosing is 10 mg/kg to a maximum of 600mg.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About ORA-Blend Oral SuspensionDrug
Oral Ibuprofen suspension (labelled as ibuprofen) given at 10 mg/kg to a maximum of 600mg each dose.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About VersaPro Cream Base for CompoundingDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 6 years to 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 6 years to 18 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Will be evaluated at study end, 18 months..
The study as a whole is currently expected to finish around 2028-03-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 60 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.