Clinical trial NCT06404177: Enantyum® IV Versus Piroxen® IM in Emergency Pain Management
Official title: Dexketoprofen ® IV Versus Piroxicam® IM in Emergency Pain Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Traumatic Injury
Lead sponsor: Hôpital Universitaire Sahloul
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomised , double blind controlled trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to pain resolution
timeFrame: 120 minutes
Secondary outcomes:
measure: rescue tratment
timeFrame: 120 minutes
measure: Side effects
timeFrame: 7 days
measure: patient satisfaction
timeFrame: 7 days
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: Sahloul University Hospital
Study officials:
References: