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

Last updated: June 27, 2023
Sponsor: University of Monastir
Overall Status: Completed

Phase

3

Condition

Acute Pain

Pain

Treatment

Paracetamol

Paracetamol caféine

Paracetamol Codeine

Clinical Study ID

NCT05229965
Codeine-Cafeine-Paracetamol
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age :18 years or older
  • Patients presented to the emergency department with acute post-traumatic pain andresidual pain at rest and/or on movement with a numerical pain rating scale (NRS) > 3/10 on discharge.
  • They all signed a written consent form.

Exclusion

Exclusion criteria:

  • Self-mutilation
  • Severe acute trauma that may require hospitalization
  • Open or complicated fracture requiring surgical management
  • Regular use of analgesics
  • Any known allergy to paracetamol, caffeine or codeine
  • Asthma and acute/chronic respiratory insufficiency
  • Severe renal insufficiency (creatinine Cl<30 ml/min)
  • Pregnant/lactating women
  • Hepatic cirrhosis.
  • Refusal, incapacity or difficulties to consent or to communicate

Study Design

Total Participants: 1500
Treatment Group(s): 3
Primary Treatment: Paracetamol
Phase: 3
Study Start date:
November 01, 2022
Estimated Completion Date:
June 27, 2023

Study 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.

Connect with a study center

  • Nouira Semir

    Monastir, 5000
    Tunisia

    Site Not Available

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