NCT05054023

Topical Piroxicam vs Soulagel in the Treatment of Acute Extremity Pain After Emergency Department Discharge

Randomized Clinical Trial of Topical Piroxicam Versus a New Herbal Medicine Based Gel in the Treatment of Acute Extremity Pain After Emergency Department Discharge

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,525 (actual)
• Sponsor: University of Monastir · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Acute soft tissues injuries are a common complaint for emergency department (ED) visit. RICE and Topical non-steroidal anti-inflammatory drugs (NSAIDs) are frequently used to reduce pain and inflammation. Herbal therapy is commonly used to treat pain but few studies assessed its efficacy and tolerability.

Detailed description

Materials and methods : Study design It is a randomized, prospective, double blind, controlled, multicentric trial. Study setting and selection of participants : The trial is conducted in three community teaching hospitals : * Emergency department, fattouma bourgiba university hospital, monastir, tunisia. * Emergency department, sahloul university hospital, sousse, tunisia. * Emergency department, farhat hached university hospital, sousse, tunisia. The study includes patients aged 18 to 60 years who presented to the ED with acute soft-tissues limb trauma pain occurring within 24 hours before presentation, with a visual numeric scale (VNS) of 5 or more on a standard 11 point (0-10) and who required a prescription for home use analgesic treatment upon discharge. An informed consent is necessary. Pain was considered traumatic if it is reported as appearing immediately after the trauma. Protocol : After medical evaluation, every patient who meet the inclusion criteria, will receive randomly either Piroxicam gel or Soulagel tubes as detailed above according to the predetermined randomization. None of the treating physician or nurses are aware about the medication received. Adhesive and/or immobilizing casts, bandages, splints, and treatment by rest, ice, compression, or elevation were prohibited after randomization. Patients could not take additional medications such as oral NSAIDs, opioids, muscle relaxants, or supplemental topical therapies. Patients were phonelly contacted in order to ensure treatment adherence and evaluate VAS once a day until the end of the treatment. After the end of the treatment, patients' satisfaction with the treatment was noted and quoted as "not satisfied", "satisfied", and "very satisfied". Need for rescue analgesic treatment was noted as well as the dose and duration. All patients were encouraged to report all adverse events during the treatment period. S All data recorded on data collection sheets, including sex, demographics, medical history, and vital signs, were entered into SPSS (version 20.0 ; IBM corps) by the research manager. Patients's informed consent is obtained. The ethic commitee of our institution approved the study.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	Soulagel®	topic gel
DRUG	Arthrosyl®	topic gel

Timeline

• Start date: 2021-10-21
• Primary completion: 2022-03-21
• Completion: 2022-03-21
• First posted: 2021-09-23
• Last updated: 2022-06-21

Locations

1 site across 1 country: Tunisia