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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain Due to Trauma
• Intervention / Treatment: Drug: Paracetamol Codeine; Drug: Paracetamol caféine; Drug: Paracetamol

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.

• Study Type: Interventional
• Enrollment (Actual): 1500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nouira Semir; Phone Number: 00216 73106046; Email: semir.nouira@rns.tn
• Study Contact Backup: Name: Nouira Semir; Phone Number: 00216 73 10 60 46; Email: semir.nouira@rns.tn

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • Nouira Semir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Paracetamol; 21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period; Other Names: 1000mg
Active Comparator: 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	Drug: Paracetamol Codeine; 14 pills will be provided with a preconised dose of 1 pill 2 times per day over 7 days period; Other Names: 500mg/ 30mg
Active Comparator: 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	Drug: Paracetamol caféine; 21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period; Other Names: 500mg/ 65mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delta Numerical Rating Scale (NRS) ( From 0 to 10 )	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 .	7 days from discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appearance of side effects	The appearance of side effects such as Drowsiness ,Decreased respiratory rate (<14 c / min), Cutaneous rash, Vomiting,Nausea,pruritus, Dizziness and Digestive hemorrhage.	7 days from discharge
Need for another analgesic medication or non-pharmacological analgesic intervention	The patient's need to add another analgesic medication or non-pharmacological analgesic intervention	7 days from discharge
Patient satisfaction assessed by Likert's verbal scale at 7 days	patient satisfaction assessed by Likert's verbal scale : with 3 responses: Satisfied; Moderately satisfied; Not satisfied	7 days from discharge

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Principal Investigator: Nouira Semir, Monastir University Hospital, Monastir, Tunisia, 5000

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: trauma; acute pain; paracetamol; codeine; cafeine
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Acetaminophen; Codeine
• Other Study ID Numbers: Codeine-Cafeine-Paracetamol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No