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Enantyum® IV Versus Piroxen® IM in Emergency Pain Management

Dexketoprofen ® IV Versus Piroxicam® IM in Emergency Pain Management

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06404177
Acronym
PiDex
Enrollment
300
Registered
2024-05-08
Start date
2023-07-15
Completion date
2024-08-30
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Injury

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.

Interventions

DRUGDexketoprofen

An intravenous perfusion of eunantyum with an intramuscular isotonic saline

intramuscular injection of piroxicam with a perfusion of isotonic saline intravenous

Sponsors

Riadh Boukef
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

prospective, randomised , double blind controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to pain resolution120 minutesVAS\<3

Secondary

MeasureTime frameDescription
rescue tratment120 minutesrate of the use of another analgesics
Side effects7 daysnumber of patients with epigastralgia , digestive bleeding, nausea, vomiting
patient satisfaction7 daysrate of satisfaction with likert scale

Countries

Tunisia

Contacts

Primary ContactRiadh Boukef, professor
riadboukef@gmail.com98676745

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026