NCT05229965

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,500 (actual)
• Sponsor: University of Monastir · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Pain Due to Trauma

Interventions

Type	Name	Description
DRUG	Paracetamol	21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period
DRUG	Paracetamol Codeine	14 pills will be provided with a preconised dose of 1 pill 2 times per day over 7 days period
DRUG	Paracetamol caféine	21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-06-27
• Completion: 2023-06-27
• First posted: 2022-02-08
• Last updated: 2023-06-28

Locations

1 site across 1 country: Tunisia