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Completed

NCT Number: NCT05229965

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nouira Semir

Monastir, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age :18 years or older
  • Patients presented to the emergency department with acute post-traumatic pain and residual 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 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

Treatment and study plan

Paracetamol

Drug

21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period

Other names: 1000mg

Paracetamol Codeine

Drug

14 pills will be provided with a preconised dose of 1 pill 2 times per day over 7 days period

Other names: 500mg/ 30mg

Paracetamol caféine

Drug

21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period

Other names: 500mg/ 65mg

Primary outcomes

  1. Delta Numerical Rating Scale (NRS) ( From 0 to 10 )

    Time frame: 7 days from discharge

    Treatment success is defined by the percentage of patients with a reduction in movement NRS at Day 7 discharge (Delta NRS ) ≥ 50% compared with NRS at emergency discharge. ( that mean a better outcome )

    Delta NRS ( in movement)=(NRS (at discharge )-NRS (day7))/(NRS (at discharge )) X 100 .

Secondary outcomes

  1. Appearance of side effects

    Time frame: 7 days from discharge

    The appearance of side effects such as Drowsiness ,Decreased respiratory rate (<14 c / min), Cutaneous rash, Vomiting,Nausea,pruritus, Dizziness and Digestive hemorrhage.

  2. Need for another analgesic medication or non-pharmacological analgesic intervention

    Time frame: 7 days from discharge

    The patient's need to add another analgesic medication or non-pharmacological analgesic intervention

  3. Patient satisfaction assessed by Likert's verbal scale at 7 days

    Time frame: 7 days from discharge

    patient satisfaction assessed by Likert's verbal scale : with 3 responses:

    • Satisfied
    • Moderately satisfied
    • Not satisfied

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2022
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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