Enantyum® IV Versus Piroxen® IM in Emergency Pain Management (PiDex)

Riadh Boukef

Status and phase: Enrolling; Phase 3

Conditions: Traumatic Injury

Treatments: Drug: Piroxicam; Drug: Dexketoprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT06404177

Dexketoprofene-Piroxicam

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups

Dexketoprofen

Experimental group

Description:

Patients receive a perfusion of Dexketoprofen in intraveinous with an injection of istonic saline IM injection

Treatment:

Drug: Dexketoprofen

Piroxicam

Active Comparator group

Description:

Patients receive an intramuscular injection of piroxicam with an intravenous isotonic saline

Treatment:

Drug: Piroxicam