Topical Diclofenac vs Oral Ibuprofen for MSK Pain in Children
(TOP-MAP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a gel applied directly to a new ankle or knee injury can relieve pain as effectively as, or better than, oral painkillers. The researchers focus on children with recent muscle or joint injuries. Participants will use both a topical gel (Diclofenac) and an oral medication (Ibuprofen) to compare their effects on pain relief. Children aged 6 to 18 with a soft-tissue injury in the ankle or knee, who have experienced pain when moving, are suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that both topical diclofenac and oral ibuprofen are generally safe for treating pain. Research involving over 11,000 people found topical diclofenac effective for sudden pain, like sprains, with few side effects, indicating it is usually well-tolerated when applied to the skin.
Oral ibuprofen is widely used and considered safe for children. Studies show it provides effective pain relief with fewer side effects compared to other pain medications and is often recommended for children over six months old.
In summary, both treatments have demonstrated safety for managing pain, with a low risk of side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because the trial compares topical diclofenac with oral ibuprofen for managing musculoskeletal (MSK) pain in children. Unlike standard oral NSAIDs like ibuprofen, which are commonly used but need to be ingested, topical diclofenac is applied directly to the skin over the affected area. This method can potentially deliver the analgesic and anti-inflammatory effects right where they're needed, possibly reducing systemic side effects associated with oral medications. Additionally, the topical application might offer a more convenient and less invasive option for children, who often dislike taking oral medication.
What evidence suggests that this trial's treatments could be effective for MSK pain in children?
This trial will compare the effectiveness of topical diclofenac and oral ibuprofen for treating muscle and joint pain in children. Research has shown that both treatments are effective. Participants in one arm of the trial will receive topical diclofenac, which studies indicate helps reduce pain, with 74% of patients finding it successful. Meanwhile, participants in another arm will receive oral ibuprofen, a trusted option for pain relief in children with these types of injuries, performing well compared to other pain relievers. Both treatments are effective, with topical diclofenac offering a promising alternative to oral ibuprofen.14678
Who Is on the Research Team?
Mohamed M Eltorki, MBChB, MSc
Principal Investigator
University of Calgary
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either topical diclofenac emulgel or oral ibuprofen three times daily for the first 3 days, followed by as-needed dosing for a total of 14 days
Follow-up
Participants are monitored for safety and effectiveness after treatment, with pain assessments on days 7 and 14
What Are the Treatments Tested in This Trial?
Interventions
- Diclofenac
- Ibuprofen
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Hamilton Health Sciences Corporation
Collaborator
Citations
Efficacy and safety of ibuprofen in children with ... - PMC - NIH
Ibuprofen provides a better pain relief with a lower incidence of adverse effects in children with musculoskeletal injuries as compared to other analgesics.
NCT03767933 | Non-Steroidal or Opioid Analgesia Use for ...
The purpose of this research study is to compare the effectiveness and safety of 3 different possible medication combinations, for the pain management of ...
Oral analgesic for musculoskeletal injuries in children
Conclusions: Our NMA found ibuprofen to be the most effective and least adverse analgesic in pediatric patients with MSK injuries. Keywords: analgesia; ...
💬 Editorial: Randomized clinical trials by Ali et al found no ...
The mean duration of symptoms before treatment was 15.1 ± 10.3 days. Results: Muscle relaxants and NSAIDs were effective in reducing pain and ...
ibuprofen in the treatment of children's inflammatory pain
ibuprofen resulted effective in several pain conditions in children such as musculoskeletal pain, ear pain and acute otitis media, toothache and the ...
20-603S001 Ibuprofen Medical Review Part 1
In support of this product's safety profile the sponsor has submitted for review the following safety data for children less than 2-years of age: 1. A new ...
Working Towards an Appropriate Use of Ibuprofen in Children
Ibuprofen is the most widely used non-steroidal anti-inflammatory drug (NSAID) for the treatment of inflammation, mild-to-moderate pain and fever in children.
Children's Ibuprofen Dosage: How Much Is Safe for Kids?
Ibuprofen (Advil, Motrin) works well for relieving pain and fever in children. Most kids ages 6 months and older can safely take this medication ...
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