Paracetamol Vs Caffeine Vs Codeine in the Management of Post Traumatic Pain in Emergencies

Acute Pain Due to Trauma Clinical Trial

Official title: Paracetamol Vs Paracetamol-Caffeine Association Vs Paracetamol-Codeine Association in the Management of Post Traumatic Pain in Emergencies

Status Completed

Clinical Trial Summary

The purpose of this study is to:

Compare the effect of paracetamol alone against Paracetamol+Codeine association against the association of paracetamol + Cafeine in the treatment of post-traumatic acute pain of the limbs.

Clinical Trial Description

At admission to the emergency department, patients with acute post-traumatic pain will be included, regardless of their initial NRS .These patients will receive the necessary care for their injury (icing, reduction, immobilization, local care, sutures), then went home with a medical prescription and an outpatient appointment .

At discharge and after obtaining their signed consent . All patients included will be randomized according to a numerical randomization table ( assigned in a 1:1:1 ratio) into 3 groups ( As a treatment for their post traumatic pain at discharge for 7 days ) :

• Group 1: Paracetamol group who will receive paracetamol ( 1000 mg) : one pill 3 times a day for 7 days .

• Group 2: Paracetamol-codeine group who will receive an association of 500 mg of Paracetamol and 30 mg of codeine : one pill twice a day for 7 days .

• Group 3: Paracetamol-cafeine group who will receive an association of 500 mg of Paracetamol and 65 mg of cafeine : one pill 3 times a day for 7 days .

For all patients included in the study, demographic and clinical data will be collected by the physician or investigator and recorded on a pre-established form.

The demographic data recorded on each patient's chart were as follows: Age, sex, origin and personal pathological history:

• Hypertension.

• Diabetes.

• Respiratory insufficiency.

• Renal insufficiency.

• Liver failure.

• Allergy.

And a Clinical examination data:

• Pain intensity (NRS).

• Mechanism of trauma and site of injury.

• Other physical examination data: systolic blood pressure (SBP), heart rate (HR) and temperature.

• Nature of traumatic injury.

• Final diagnosis

• Injury Severity Score (ISS).

• NRS at discharge (at rest and on movement).

Patients included will be assessed at Day 1 , Day 2 , Day 3 and Day 7 after discharge from the emergency department by a telephone call. This evaluation will include :

• NRS at rest and during movement

• Secondary use of another analgesic.

• Patient satisfaction assessed by Likert scale, with 3 responses:

• Satisfied

• Moderately satisfied

• Not satisfied

• Side effects: epigastralgia, dizziness, somnolence, headache, nausea and/or vomiting, insomnia, constipation, palpitation, etc. ;

Related Conditions & MeSH terms

• Acute Pain
• Acute Pain Due to Trauma
• Emergencies

• NCT number: NCT05229965
• Study type: Interventional
• Source: University of Monastir
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2022
• Completion date: June 27, 2023