Enantyum® IV Versus Piroxen® IM in Emergency Pain Management

Traumatic Injury Clinical Trial

— PiDex  

Official title:

Dexketoprofen ® IV Versus Piroxicam® IM in Emergency Pain Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06404177
• Other study ID #: Dexketoprofene-Piroxicam
• Status: Recruiting
• Phase: Phase 3
• Start date: July 15, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: May 2024
• Source: Hôpital Universitaire Sahloul
• Contact: Riadh Boukef, professor
• Phone: 98676745
• Email: riadboukef[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 30, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Traumatic Injury
• Wounds and Injuries

Intervention

Drug:
• Dexketoprofen
An intravenous perfusion of eunantyum with an intramuscular isotonic saline
• Piroxicam
intramuscular injection of piroxicam with a perfusion of isotonic saline intravenous

Locations

Country	Name	City	State
Tunisia	Sahloul University Hospital	Sousse

Sponsors (1)

Lead Sponsor	Collaborator
Riadh Boukef

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to pain resolution	VAS<3	120 minutes
Secondary	rescue tratment	rate of the use of another analgesics	120 minutes
Secondary	Side effects	number of patients with epigastralgia , digestive bleeding, nausea, vomiting	7 days
Secondary	patient satisfaction	rate of satisfaction with likert scale	7 days