Musculoskeletal InjuryPhase 3TOP-MAPNCT07145645
Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children
A Phase 3 study testing Voltaren Topical Gel, Ibuprofen Oral Suspension 100 mg/5mL and ORA-Blend Oral Suspension in people with Musculoskeletal Injury and Pediatrics, run by University of Calgary at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Musculoskeletal Injury, Pediatrics, Sprain and Strain of Ankle
- What is being tested?
- Voltaren Topical Gel, Ibuprofen Oral Suspension 100 mg/5mL and ORA-Blend Oral Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- 2 Apr 2026to 31 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Angela Project Lead, 403-955-5451, angela.wallace@ucalgary.ca
Mohamed Principal Investigator, 403-955-5373, mmeltork@ucalgary.ca
- Not yet recruiting
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
Samina Site Investigator, 780-248-5574, sali@ualberta.ca
Samina Ali, MD
About this study
Official title: Topical Diclofenac vs. Oral Ibuprofen for Musculoskeletal Pain in Children: A Multi-centre, Randomized Pilot Feasibility 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.
Read the detailed description
In Canada, musculoskeletal sprains and strains account for 10% of Emergency department visits in children aged 10-17 years of age. Unlike upper limb injuries, which are often fractured, injuries to the ankle and knees are non-fractured soft tissue injuries in 88% and 91% respectively. Management of such injuries is focused on pain and inflammation management through pharmacotherapy, cryotherapy and early mobilization while avoiding casting.
Oral ibuprofen, a non-steroidal anti-inflammatory drug (NSAID) is the recommended first-line pharmacotherapy for mild to moderate musculoskeletal (MSK) injury related pain. However, alternatives such as topical NSAIDs (e.g., diclofenac emulgel) are commonly recommended in adults. Among adults their effect is equivalent to oral NSAIDs and they can be directly applied to the injured area resulting in a lower risk of systemic adverse events (AE's). Despite their frequent use in adults, topical NSAIDs are currently not recommended for children due to a lack of supporting data.
Based on adult data, the investigators hypothesize that topical NSAIDs provide similarly effective pain management to oral NSAIDs in children with acute MSK injuries with a reduced risk of systemic AEs. This pilot trial will assess the feasibility of a definitive non-inferiority trial of topical diclofenac emulgel vs. oral ibuprofen for children with acute ankle or knee soft tissue injuries. The results of a definitive trial have the potential to alter current pediatric MSK injury management if topical diclofenac emulgel is indeed non-inferior to oral ibuprofen for pain relief, with an expected lower risk of systemic AEs.
In children aged 6 to <18 years with an acute (≤4-days) ankle or knee non-fractured soft tissue injury (e.g., sprain, strain or contusion), is topical diclofenac emulgel 11.6 mg/g non-inferior to oral ibuprofen (both administered three times daily) in reducing pain during the 72 hours following ED discharge? This pilot randomized, double-dummy, blinded (participants, clinicians, outcome assessors, investigators), two-centre ED trial will enroll 60 participants, following the 2010 CONSORT statement.
Study medications will be administered simultaneously to maintain masking of participants and accuracy of pain assessments, three times daily for the first 72 hours, followed by as-needed dosing for a total of 14 days.
This pilot will inform the planning of a definitive trial by assessing a) feasibility of recruiting patients in EDs; b) acceptability of interventions; c) ability to collect at-home pain assessments; d) identifying pain assessment time-point with the highest completion and effect; and e) refining sample size calculations from variance around clinical outcomes data. The investigators will evaluate the impact of the eligibility criteria and identify which groups of children are being excluded and why. This data will be used to inform discussions to finalize the eligibility criteria.
- Being tested
- Voltaren Topical Gel, Ibuprofen Oral Suspension 100 mg/5mL, ORA-Blend Oral Suspension, VersaPro Cream Base for Compounding
- Keywords
- Non Steroidal Anti-Inflammatory, Pediatric Emergency Department, Pediatrics, Ankle or Knee Injury, Topical NSAIDs
- Medical subject headings
- Sprains and Strains, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voltaren Topical GelDrug
Also called diclofenac emulgel, diclofenac diethylamine
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/5mLDrug
Also called Children's Motrin, Ibuprofen Oral Suspension
Children's Ibuprofen Oral suspension (Motrin) 100mg/5 mL . Dosing is 10 mg/kg to a maximum of 600mg.
ORA-Blend Oral SuspensionDrug
Oral Ibuprofen suspension (labelled as ibuprofen) given at 10 mg/kg to a maximum of 600mg each dose.
VersaPro Cream Base for CompoundingDrug
Also called Versapro Gel
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ibuprofen Oral Suspension 100 mg/5mL; Drug: VersaPro Cream Base for Compounding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- The investigators aim to achieve a 50% consent rate from all eligible candidates approached to participate.
- 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.
- 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.
Measured: Will be evaluated at study end, 18 months.
Secondary outcomes (1)
Pain relief as measured on the verbal Numerical Rating scale.
To assess between group mean differences in reported pain scores as measured on the 11-point verbal numerical scale. The vNRS is scaled from 0 (no pain) to 10 (worst pain).
Measured: First 24 hours after ED discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start2 Apr 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal InjuryStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Mohamed M Eltorki, MBChB, MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145645
- Sponsor's protocol ID
- TOPMAP-25-02-2025
- Acronym
- TOP-MAP
- Status last verified
- Jul 2025
- First submitted
- 14 Aug 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, anonymized data that give support to the results reported in the study may be shared with other researchers. Any data that could potentially identify participants due to a low N (ie; race data reported of less than 5) will not be shared.
Publications
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.)
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.
PubMed 36794826
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Diclofenac vs. Oral Ibuprofen for Musculoskeletal Pain in Children: A Multi-centre, Randomized Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT07145645
- Acronym / sponsor ID
- TOP-MAP / TOPMAP-25-02-2025
- Keywords
- Non Steroidal Anti-Inflammatory, Pediatric Emergency Department, Pediatrics, Ankle or Knee Injury, Topical NSAIDs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In Canada, musculoskeletal sprains and strains account for 10% of Emergency department visits in children aged 10-17 years of age. Unlike upper limb injuries, which are often fractured, injuries to the ankle and knees are non-fractured soft tissue injuries in 88% and 91% respectively. Management of such injuries is focused on pain and inflammation management through pharmacotherapy, cryotherapy and early mobilization while avoiding casting.
Oral ibuprofen, a non-steroidal anti-inflammatory drug (NSAID) is the recommended first-line pharmacotherapy for mild to moderate musculoskeletal (MSK) injury related pain. However, alternatives such as topical NSAIDs (e.g., diclofenac emulgel) are commonly recommended in adults. Among adults their effect is equivalent to oral NSAIDs and they can be directly applied to the injured area resulting in a lower risk of systemic adverse events (AE's). Despite their frequent use in adults, topical NSAIDs are currently not recommended for children due to a lack of supporting data.
Based on adult data, the investigators hypothesize that topical NSAIDs provide similarly effective pain management to oral NSAIDs in children with acute MSK injuries with a reduced risk of systemic AEs. This pilot trial will assess the feasibility of a definitive non-inferiority trial of topical diclofenac emulgel vs. oral ibuprofen for children with acute ankle or knee soft tissue injuries. The results of a definitive trial have the potential to alter current pediatric MSK injury management if topical diclofenac emulgel is indeed non-inferior to oral ibuprofen for pain relief, with an expected lower risk of systemic AEs.
In children aged 6 to <18 years with an acute (≤4-days) ankle or knee non-fractured soft tissue injury (e.g., sprain, strain or contusion), is topical diclofenac emulgel 11.6 mg/g non-inferior to oral ibuprofen (both administered three times daily) in reducing pain during the 72 hours following ED discharge? This pilot randomized, double-dummy, blinded (participants, clinicians, outcome assessors, investigators), two-centre ED trial will enroll 60 participants, following the 2010 CONSORT statement.
Study medications will be administered simultaneously to maintain masking of participants and accuracy of pain assessments, three times daily for the first 72 hours, followed by as-needed dosing for a total of 14 days.
This pilot will inform the planning of a definitive trial by assessing a) feasibility of recruiting patients in EDs; b) acceptability of interventions; c) ability to collect at-home pain assessments; d) identifying pain assessment time-point with the highest completion and effect; and e) refining sample size calculations from variance around clinical outcomes data. The investigators will evaluate the impact of the eligibility criteria and identify which groups of children are being excluded and why. This data will be used to inform discussions to finalize the eligibility criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active topical Diclofenac Diethylamine emulgel | Experimental | Drug: Voltaren Topical Gel, Drug: ORA-Blend Oral SuspensionTopical 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 Ibuprofen suspension | Active comparator | Drug: Ibuprofen Oral Suspension 100 mg/5mL, Drug: VersaPro Cream Base for CompoundingActive 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voltaren Topical GelAlso: diclofenac emulgel, diclofenac diethylamineTopical 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. | Drug | Active topical Diclofenac Diethylamine emulgel |
| Ibuprofen Oral Suspension 100 mg/5mLAlso: Children's Motrin, Ibuprofen Oral SuspensionChildren's Ibuprofen Oral suspension (Motrin) 100mg/5 mL . Dosing is 10 mg/kg to a maximum of 600mg. | Drug | Active Ibuprofen suspension |
| ORA-Blend Oral SuspensionOral Ibuprofen suspension (labelled as ibuprofen) given at 10 mg/kg to a maximum of 600mg each dose. | Drug | Active topical Diclofenac Diethylamine emulgel |
| VersaPro Cream Base for CompoundingAlso: Versapro GelTopical 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. | Drug | Active Ibuprofen suspension |
Primary outcome
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.
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.
1 secondary outcome
Pain relief as measured on the verbal Numerical Rating scale.
Time frame: First 24 hours after ED discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Results publicationChildHealth 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.)
- Results publication: PubMed 36794826Wang 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.
- Individual participant dataSharing planned: Yes. De-identified, anonymized data that give support to the results reported in the study may be shared with other researchers. Any data that could potentially identify participants due to a low N (ie; race data reported of less than 5) will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed M Eltorki, MBChB, MSc principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Voltaren Topical Gel, Ibuprofen Oral Suspension 100 mg/5mL and ORA-Blend Oral Suspension in people with Musculoskeletal Injury and Pediatrics, run by University of Calgary at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M Eltorki, MBChB, MSc (403-955-7723, mmeltork@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07145645, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.