[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604140":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":49,"centralContacts":53,"locations":62,"responsibleParty":105,"collaborators":107,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":112,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":42,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":134,"overallStatus":65,"whyStopped":42,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"University of Calgary","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"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.\n\nParticipants randomized to the experimental arm will be given topical diclofenac gel (11.6 mg\u002Fg). Dosing is based on the following weight bands:\n\n25 kg: 2 grams\u002Fdose;\n\n≥25 kg - \\\u003C40 kg: 3 grams\u002Fdose; and \\>40 kg: 4 grams\u002Fdose.",[13,14],"Drug: Voltaren Topical Gel","Drug: ORA-Blend Oral Suspension",{"label":16,"type":17,"description":18,"interventionNames":19},"Active Ibuprofen suspension","ACTIVE_COMPARATOR","Active oral ibuprofen suspension. The ibuprofen suspension dose is 10 mg\u002Fkg 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.",[20,21],"Drug: Ibuprofen Oral Suspension 100 mg\u002F5mL","Drug: VersaPro Cream Base for Compounding",[23,31,38,43],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Voltaren Topical Gel","Topical diclofenac emulgel (Voltaren) 11.6 mg\u002Fg. Dosing is based on weight bands: 25 kg: 2 grams\u002Fdose, ≥25 kg - \\\u003C40 kg: 3 grams\u002Fdose; and \\>40 kg: 4 grams\u002Fdose. ATC code: M02A A15.",[9],[29,30],"diclofenac emulgel","diclofenac diethylamine",{"type":24,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Ibuprofen Oral Suspension 100 mg\u002F5mL","Children's Ibuprofen Oral suspension (Motrin) 100mg\u002F5 mL . Dosing is 10 mg\u002Fkg to a maximum of 600mg.",[16],[36,37],"Children's Motrin","Ibuprofen Oral Suspension",{"type":24,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"ORA-Blend Oral Suspension","Oral Ibuprofen suspension (labelled as ibuprofen) given at 10 mg\u002Fkg to a maximum of 600mg each dose.",[9],null,{"type":24,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"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\u002Fdose;\n\n≥25 kg - \\\u003C40 kg: 3 grams\u002Fdose; and \\>40 kg: 4 grams\u002Fdose.",[16],[48],"Versapro Gel",[50],{"name":51,"affiliation":5,"role":52},"Mohamed M Eltorki, MBChB, MSc","PRINCIPAL_INVESTIGATOR",[54,58],{"name":51,"role":55,"phone":56,"phoneExt":42,"email":57},"CONTACT","403-955-7723","mmeltork@ucalgary.ca",{"name":59,"role":55,"phone":60,"phoneExt":42,"email":61},"Angela C Wallace, BA","403-955-5451","angela.wallace@ucalgary.ca",[63,88],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Alberta Children's Hospital","RECRUITING","Calgary","Alberta","T3B 6A8","Canada","CA",{"type":72,"coordinates":73},"Point",[74,75],-114.08529,51.05011,{"lat":75,"lon":74},[78,80,83,85],{"name":79,"role":55,"phone":60,"phoneExt":42,"email":61},"Angela Project Lead",{"name":81,"role":55,"phone":82,"phoneExt":42,"email":57},"Mohamed Principal Investigator","403-955-5373",{"name":84,"role":52,"phone":42,"phoneExt":42,"email":42},"Mohamed Eltorki, MD, MBChB",{"name":86,"role":87,"phone":42,"phoneExt":42,"email":42},"Stephen Freedman, MD","SUB_INVESTIGATOR",{"facility":89,"status":90,"city":91,"state":67,"zip":92,"country":69,"countryCode":70,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Stollery Children's Hospital","NOT_YET_RECRUITING","Edmonton","T6G 2B7",{"type":72,"coordinates":94},[95,96],-113.46871,53.55014,{"lat":96,"lon":95},[99,103],{"name":100,"role":55,"phone":101,"phoneExt":42,"email":102},"Samina Site Investigator","780-248-5574","sali@ualberta.ca",{"name":104,"role":52,"phone":42,"phoneExt":42,"email":42},"Samina Ali, MD",{"type":106,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[108],{"name":109,"class":6},"Hamilton Health Sciences Corporation","100604140","phase-3-topical-diclofenac-vsoral-ibuprofen-for-msk-pain-in-children-100604140",false,"NCT07145645","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","TOP-MAP","Inclusion Criteria:\n\n1. Age 6 to 18 years old.\n2. Injury less than or equal to 4 days old\n3. Non-fractured MSK soft-tissue injury (ankle or knee, confirmed clinically and\u002For radiographically)\n4. 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\n5. Willing and able to complete follow-up surveys as per study protocol\n\nExclusion Criteria:\n\n1. Previous enrolment in the trial\n2. 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.\n3. 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\n4. 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\n5. Taking NSAIDs daily for other indications (e.g, chronic pain or arthritis)\n6. Known hypersensitivity to ibuprofen, diclofenac or other NSAIDs.\n7. Any known allergy or intolerance to any components or trace constituents (e.g., aloe vera, tree nuts or corn) of the investigational products\n8. 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\n9. Absence of a parent\u002Fguardian for children who are not mature minors.\n10. Caregiver and\u002For child cognitive impairment precluding the ability to complete study procedures\n11. Inability to obtain consent, and to complete follow-up surveys due to language barrier\n12. 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\n13. 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","ALL","6 Years","18 Years",{"count":122,"type":123},60,"ESTIMATED","INTERVENTIONAL",[126],"PHASE3","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.\n\nThe 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.",[129,130,131,132,133],"Musculoskeletal Injury","Pediatrics","Sprain and Strain of Ankle","Sprain Knee","Strain Knee",[135,136,130,137,138],"Non Steroidal Anti-Inflammatory","Pediatric Emergency Department","Ankle or Knee Injury","Topical NSAIDs","2026-04-07",{"date":141,"type":142},"2026-04-13","ACTUAL",{"date":144,"type":142},"2026-04-02",{"date":146,"type":123},"2028-03-31",{"name":5,"class":6},2]