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

Codeine-Cafeine-Paracetamol

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.

2022-11-01

2023-06-27

2023-06-27

Completed

Early phase I

1500

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'study medications consists of a randomly sequence generated numbers.\n\npatients and the research associate who collected the outcome data are blinded from the study group', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 1500, 'type': 'ACTUAL'}}

2023-06-28