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

  • days left to enroll
  • participants needed
  • sponsor
    University of Monastir
Updated on 20 October 2022


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.


Paracetamol, Paracetamol-Codeine, or Paracetamol-Cafeine are usually prescribed. Patients even use these medications without a prescription.

All patients were assigned in a 1:1:1 ratio to receive randomization of subjects performed centrally according to a computer-generated random code provided by one of investigators who was not involved in any other part of the trial. The patients included were divided into 3 groups: Paracetamol group who received paracetamol 1000 mg orally 3 times a day; Paracetamol-codeine group who received twice a day an association of 500 mg of Paracetamol and 30 mg of codeine, paracetamol-cafeine group who received twice a day an association of 500 mg of Paracetamol and 65 mg of cafeine.

All protocol treatments were administered according to the randomization list by an independent nurse who was not involved in monitoring or follow-up of the individuals. Data were collected for each patient, including demographics, medical history, findings of the clinical examination, the type of injury and its localisatio, The Visual Analogue Scale (VAS) at admission and at discharge from the Emergency Departement (ED), the treatment received in the ED (the analgesia's type: opioid or other) as well as the care provided there such as stitches, plaster, splint, reduction of the fracture. Injury Severity Score (ISS) whose values range from 0 to 75 was also assessed. Each patient was re-evaluated on the 3rd and 7th day post-trauma (D7) using a telephone contact by a clinical research associates who was blinded to the details of the study to note the following clinical data: pain VNS, ED readmissions for residual pain, need for other analgesics other than those of the protocol, other treatment modalities the patient might have used (adherence to the treatment prescribed), and side effects. In addition patients were asked about their satisfaction with pain control following ED using five point Likert scale: very dissatisfied, not satisfied, neutral, satisfied and very satisfied and about the degree to which they adhered to medication schedule. The principal investigator who was aware of the allocation was not involved in monitoring or recording of the outcomes until the data collection was completed.

Condition Acute Pain Due to Trauma
Treatment Paracetamol, Codeine, Caféine, Caféine
Clinical Study IdentifierNCT05229965
SponsorUniversity of Monastir
Last Modified on20 October 2022


Yes No Not Sure

Inclusion Criteria

age 18 years or older
acute (<24 hours) post traumatic pain of the extremity and requiring analgesic treatment upon discharge for pain with intensity >3 on a visual numeric scale

Exclusion Criteria

open fracture head, abdominal, thoracic or polytrauma
Need for hospitalization, regular use of paracetamol and NSAIDs during the two weeks before admission to ED history of allergy or hypersensitivity to either paracetamol or Codeine or cafeine
acute /history of GI hemorrhage and renal insufficiency
an inability to assess pain intensity according to the VNS
heart failure
known hepatic cirrhosis
known severe renal impairment (Creatinine clearance <30 ml/min)
swallowing disorders
Refusal, incapacity or difficulties to consent or to communicate
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