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

• Status: Completed
• Trial end date: 2020-10-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Monastir
• Treatments: Piroxicam

Criteria

Inclusion Criteria:

• Patients who presented to the ED with acute non-penetrating minor soft tissues musculoskeletal limb trauma occurring within 24 hours before presentation, and who required a prescription for home use analgesic treatment upon discharge for pain-on-movement (POM) with intensity >50 on a visual numeric scale (VNS) on a standard 11 point (0-10).

• Pain was considered traumatic if it is reported as appearing immediately after the trauma and no anterior pain was described in the same limb.

Exclusion Criteria:

• Pregnancy/Breastfeeding

• Skin lesions (excessive dryness or redness of the skin, atopic dermatitis, and eczema) in the painful region

• Presence of wound, joint dislocation, or more than one injury

• Presence of a fracture

• Severe trauma (ISS > 16)

• Hospitalization or surgery, daily use of NSAIDs or other analgesia within 2 weeks

• Previous treatment with analgesia for the same injury

• History of previous adverse reaction or known allergy or hypersensitivity

• Physical, visual, or cognitive impairment (inability to use the VNS pain score)

• Refusal to consent or to communicate