Enantyum® IV Versus Piroxen® IM in Emergency Pain Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-15

Study Completion Date

2024-08-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Traumatic Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, randomised , double blind controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexketoprofen

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

Group Type EXPERIMENTAL

Dexketoprofen

Intervention Type DRUG

An intravenous perfusion of eunantyum with an intramuscular isotonic saline

Piroxicam

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

Group Type ACTIVE_COMPARATOR

Piroxicam

Intervention Type DRUG

intramuscular injection of piroxicam with a perfusion of isotonic saline intravenous

Interventions

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Dexketoprofen

An intravenous perfusion of eunantyum with an intramuscular isotonic saline

Intervention Type DRUG

Piroxicam

intramuscular injection of piroxicam with a perfusion of isotonic saline intravenous

Intervention Type DRUG

Other Intervention Names

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Placebo IM placebo IV

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No