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

NCT ID: NCT05229965

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-06-27

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Paracétamol Group

In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracétamol Caféine Group) .

In Paracetamol group , the patients will receive a pill containing 1000 mg of paracetamol 3 times a day for 7 days .

Paracétamol 1000 mg : 1 pill *3 / day

Group Type: ACTIVE_COMPARATOR

Paracetamol

Intervention Type: DRUG

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

Paracétamol Codéine Group

In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracetamol Caféine Group) .

In Paracetamol codéine group , the patients will receive a pill containing an association of paracetamol and codéine ( 500mg / 30mg ) 3 times a day for 7 days .

-Association of Paracétamol and Codéine ( 500mg / 30 mg) : 1 pill *2 /day

Group Type: ACTIVE_COMPARATOR

Paracetamol Codeine

Intervention Type: DRUG

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

Paracétamol Caféine Group

In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracetamol Caféine Group) .

In Paracetamol caféine group , the patients will receive a pill containing an association of paracetamol and caféine ( 500mg / 65 mg ) 3 times a day for 7 days .

-Association of Paracétamol and Caféine ( 500mg / 65 mg) : 1 pill *3 /day

Group Type: ACTIVE_COMPARATOR

Paracetamol caféine

Intervention Type: DRUG

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

Interventions

Paracetamol

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

Intervention Type: DRUG

Paracetamol Codeine

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

Intervention Type: DRUG

Paracetamol caféine

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

Intervention Type: DRUG

Other Intervention Names

1000mg; 500mg/ 30mg; 500mg/ 65mg

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Pr. Semir Nouira

PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nouira Semir

Role: PRINCIPAL_INVESTIGATOR

Monastir University Hospital, Monastir, Tunisia, 5000

Locations

Nouira Semir

Monastir, , Tunisia

Countries

Tunisia

Other Identifiers

Codeine-Cafeine-Paracetamol

Identifier Type: -

Identifier Source: org_study_id