NCT06404177

Enantyum® IV Versus Piroxen® IM in Emergency Pain Management

Dexketoprofen ® IV Versus Piroxicam® IM in Emergency Pain Management

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Riadh Boukef · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

For pain of traumatic origin, the RICE protocol (Rest, Ice, Compression, Elevation) is the main therapeutic measure during the first 4 to 5 days post-trauma. However, there is currently insufficient evidence that this protocol is effective \[4\]. In the emergency department, paracetamol, NSAIDs or a combination of several molecules are generally prescribed. Patients even use these drugs without a prescription. The aim of this study is to Compare the effect of dexketoprofen® IV versus piroxen® IM in the treatment of pain in emergency departments.

Detailed description

This was a prospective, randomized, double-blind, controlled study conducted at the Sahloul emergency department, Sousse. Study duration: 3 months. Inclusion criteria: Patients over 18 years of age requiring analgesia for acute pain of traumatic origin and who signed a written consent form were included in this study. Exclusion criteria: Patients who meet the following conditions: * refusal, incapacity, difficulties with consent or communication * Patients with chronic pain. * Any known allergy or secondary reaction to piroxen or dexketoprofen trometamol. * Pregnant women. * Cirrhosis of the liver. Methodology: 1. Dexketoprofen group Patient receives an intravenous injection of Dexketoprofen + IM placebo + follow-up sheet + appointment card. 2. Piroxican group. Patients receive one intramuscular Piroxen injection + IV SSI infusion + follow-up sheet + appointment card. For each patient included, VAS, blood pressure, heart rate, respiratory rate and Sa02 are taken on admission and discharge from the emergency department, and at the second telephone visit after 07 days. At the 7th day visit (by telephone), patients were asked to answer satisfaction questions and complete the EQ50 quality of life questionnaire.

Conditions

• Traumatic Injury

Interventions

Type	Name	Description
DRUG	Dexketoprofen	An intravenous perfusion of eunantyum with an intramuscular isotonic saline
DRUG	Piroxicam	intramuscular injection of piroxicam with a perfusion of isotonic saline intravenous

Timeline

• Start date: 2023-07-15
• Primary completion: 2024-08-01
• Completion: 2024-08-30
• First posted: 2024-05-08
• Last updated: 2024-05-08

Locations

1 site across 1 country: Tunisia