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

Dexketoprofen ® IV Versus Piroxicam® IM in Emergency Pain Management

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Injury
• Intervention / Treatment: Drug: Dexketoprofen; Drug: Piroxicam

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: riadh boukef, professor; Phone Number: 216 98676745; Email: riadboukef@gmail.com

Study Locations

• Tunisia
  • Sousse, Tunisia, 5000
    • Recruiting
    • Sahloul University Hospital
    • Contact: riadh boukef, professor; Phone Number: 216 98676745; Email: riadboukef@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexketoprofen; Patients receive a perfusion of Dexketoprofen in intraveinous with an injection of istonic saline IM injection	Drug: Dexketoprofen; An intravenous perfusion of eunantyum with an intramuscular isotonic saline; Other Names: Placebo IM
Active Comparator: Piroxicam; Patients receive an intramuscular injection of piroxicam with an intravenous isotonic saline	Drug: Piroxicam; intramuscular injection of piroxicam with a perfusion of isotonic saline intravenous; Other Names: placebo IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to pain resolution	VAS<3	120 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Riadh Boukef

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: May 4, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 4, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Wounds and Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Dexketoprofen trometamol; Piroxicam
• Other Study ID Numbers: Dexketoprofene-Piroxicam

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No