Enantyum® IV Versus Piroxen® IM in Emergency Pain Management

Last updated: May 4, 2024
Sponsor: Riadh Boukef
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Dexketoprofen

Piroxicam

Clinical Study ID

NCT06404177
Dexketoprofene-Piroxicam
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Dexketoprofen
Phase: 3
Study Start date:
July 15, 2023
Estimated Completion Date:
August 30, 2024

Study 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.

Connect with a study center

  • Sahloul University Hospital

    Sousse, 5000
    Tunisia

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.