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NCT05647681
Analgesic Effect of a New Analgesic Based Gel(Douloff) Versus Oral Paracetamol in Acute Soft Injuries
Conditions: Analgesia
Sex: All
Ages: 18 Years – 60 Years
Phase: PHASE1
Enrollment: 1500
Sponsor: University of Monastir
Summary
Herbal medicine is commonly used to treat pain, but little is known about its effectiveness and its place in the common arsenal of analgesics .The question of whether such herbal combinations could have similar efficacy to oral analgesics in the treatment of post-traumatic soft tissue pain has not yet been investigated.
Thus, we conducted this multi-center randomized controlled trial to determine the efficacy and tolerability of a new topical herbal preparation (Douloff®) compared to oral paracetamol in the treatment of acute pain secondary to soft tissue injury.
Eligibility Criteria
Inclusion Criteria:Patients are eligible for enrollment if they are over 60 years of age, present to the emergency department with minor non-penetrating musculoskeletal soft tissue trauma occurring within 24 hours prior to admission to the emergency department, and require a prescription for home analgesic treatment at discharge: pain on movement (POM) with an intensity> 50 on a visual numeric scale (VNS) ranging from 0 to 10 (0 = no pain, 10 = maximum pain)Exclusion Criteria:Patients were excluded from the study:If they had skin lesions (dryness or excessive redness of the skin, atopic dermatitis and eczema) in the painful area The presence of a wound, joint dislocation or multiple injuries.
The presence of a fracture Patients with severe trauma (Injury Severity Score > 16) The need for hospitalization or surgery Daily use of NSAIDs or other analgesics in the 2 weeks before presentation, and previous treatment with analgesia for the same injury Contraindications to any of the drugs in the protocol, including a history of previous adverse events or a known allergy or hypersensitivity.Pregnant or lactating women Inability to use the VNS pain score refusal to consent or communicate
Source: ClinicalTrials.gov (NCT05647681). StuddyBuddy aggregates publicly available trial information.