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

NCT05229965 | Completed Phase 3 DMC

• 1 other identifier: Codeine-Cafeine-Paracetamol
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain Due to Trauma

Keywords

acute pain; trauma; paracetamol; codeine; cafeine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Appearance of side effects

  7 days from discharge

• Need for another analgesic medication or non-pharmacological analgesic intervention

  7 days from discharge

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

  7 days from discharge

Study Arms (3)

Paracétamol Group

ACTIVE COMPARATOR

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

Paracétamol Codéine Group

ACTIVE COMPARATOR

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

Paracétamol Caféine Group

ACTIVE COMPARATOR

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

Interventions

Paracetamol DRUG

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

Also known as: 1000mg

Paracétamol Group

Paracetamol Codeine DRUG

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

Also known as: 500mg/ 30mg

Paracétamol Codéine Group

Paracetamol caféine DRUG

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

Also known as: 500mg/ 65mg

Paracétamol Caféine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Nouira Semir

Monastir, 5000, Tunisia

Location

MeSH Terms

Conditions

Acute Pain; Wounds and Injuries

Interventions

Acetaminophen; acetaminophen, codeine drug combination

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Nouira Semir

  Monastir University Hospital, Monastir, Tunisia, 5000

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: study medications consists of a randomly sequence generated numbers. patients and the research associate who collected the outcome data are blinded from the study group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: February 8, 2022
• Study Start: November 1, 2022
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)