Paracetamol Vs Paracetamol-Caffeine Association Vs Paracetamol-Codeine Association in the Management of Post Traumatic Pain in Emergencies
-
- STATUS
- Recruiting
-
- days left to enroll
- 56
-
- participants needed
- 1500
-
- sponsor
- University of Monastir
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.
Description
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.
Details
| Condition | Acute Pain Due to Trauma |
|---|---|
| Treatment | Paracetamol, Codeine, Caféine, Caféine |
| Clinical Study Identifier | NCT05229965 |
| Sponsor | University of Monastir |
| Last Modified on | 20 October 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer