Enantyum® IV Versus Piroxen® IM in Emergency Pain Management

Phase 3

Recruiting

• Conditions: Traumatic Injury
• Interventions: Drug: Dexketoprofen; Drug: Piroxicam

• Registration Number: NCT06404177
• Lead Sponsor: Riadh Boukef

Brief 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.

Study Timeline

• Study First Submitted: 2023-07-03
• Study Start: 2023-07-15
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-04
• Last Update Submitted: 2024-05-04
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients over 18 years of age who required analgesia for acute pain of traumatic origin and who signed a written consent form were included in the 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexketoprofen	Dexketoprofen	Patients receive a perfusion of Dexketoprofen in intraveinous with an injection of istonic saline IM injection
Piroxicam	Piroxicam	Patients receive an intramuscular injection of piroxicam with an intravenous isotonic saline

Primary Outcome Measures

Name	Time	Method
Time to pain resolution	120 minutes	VAS\<3

Secondary Outcome Measures

Name	Time	Method
rescue tratment	120 minutes	rate of the use of another analgesics
Side effects	7 days	number of patients with epigastralgia , digestive bleeding, nausea, vomiting
patient satisfaction	7 days	rate of satisfaction with likert scale

Trial Locations

Locations (1)

Sahloul University Hospital; 🇹🇳 Sousse, Tunisia