Enantyum® IV Versus Piroxen® IM in Emergency Pain Management

NCT06404177 | Recruiting Phase 3

• 1 other identifier: Dexketoprofene-Piroxicam
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Injury

Outcome Measures

Primary Outcomes (1)

• Time to pain resolution

  VAS\<3

  120 minutes

Secondary Outcomes (3)

• rescue tratment

  120 minutes

• Side effects

  7 days

• patient satisfaction

  7 days

Study Arms (2)

Dexketoprofen

EXPERIMENTAL

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

Drug: Dexketoprofen

Piroxicam

ACTIVE COMPARATOR

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

Drug: Piroxicam

Interventions

Dexketoprofen DRUG

An intravenous perfusion of eunantyum with an intramuscular isotonic saline

Also known as: Placebo IM

Dexketoprofen

Piroxicam DRUG

intramuscular injection of piroxicam with a perfusion of isotonic saline intravenous

Also known as: placebo IV

Piroxicam

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riadh Boukef: lead

Study Sites (1)

Sahloul University Hospital

Sousse, 5000, Tunisia

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

dexketoprofen trometamol; Piroxicam

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Riadh Boukef, professor

CONTACT

98676745; riadboukef@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: prospective, randomised , double blind controlled trial

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: May 8, 2024
• Study Start: July 15, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 30, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

TU (1)