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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Pain Due to Trauma

Intervention / Treatment
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* Drug: Paracetamol
* Drug: Paracetamol Codeine
* Drug: Paracetamol caféine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paracétamol Group<br>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<br>* 21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period<br>* Other names: 1000mg;|
| Active Comparator: Paracétamol Codéine Group<br>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<br>* 14 pills will be provided with a preconised dose of 1 pill 2 times per day over 7 days period<br>* Other names: 500mg/ 30mg;|
| Active Comparator: Paracétamol Caféine Group<br>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<br>* 21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period<br>* Other names: 500mg/ 65mg;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute pain, trauma, paracetamol, codeine, cafeine