Clinical trial NCT05229965: Paracetamol Vs Caffeine Vs Codeine in the Management of Post Traumatic Pain in Emergencies
Official title: Paracetamol Vs Paracetamol-Caffeine Association Vs Paracetamol-Codeine Association in the Management of Post Traumatic Pain in Emergencies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain Due to Trauma
Keywords: acute pain
trauma
paracetamol
codeine
cafeine
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Delta Numerical Rating Scale (NRS) ( From 0 to 10 )
timeFrame: 7 days from discharge
Secondary outcomes:
measure: Appearance of side effects
timeFrame: 7 days from discharge
measure: Need for another analgesic medication or non-pharmacological analgesic intervention
timeFrame: 7 days from discharge
measure: Patient satisfaction assessed by Likert's verbal scale at 7 days
timeFrame: 7 days from discharge
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Nouira Semir
Study officials:
affiliation: Monastir University Hospital, Monastir, Tunisia, 5000
name: Nouira Semir
role: PRINCIPAL_INVESTIGATOR
References: