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

Sponsor
University of Monastir (Other)
Overall Status
Completed
CT.gov ID
NCT05229965
Collaborator
(none)
1,500
1
3
11.9
126.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
study medications consists of a randomly sequence generated numbers. patients and the research associate who collected the outcome data are blinded from the study group
Primary Purpose:
Treatment
Official Title:
Paracetamol Vs Paracetamol-Caffeine Association Vs Paracetamol-Codeine Association in the Management of Post Traumatic Pain in Emergencies
Actual Study Start Date :
Aug 1, 2021
Actual Primary Completion Date :
Apr 13, 2022
Actual Study Completion Date :
Jul 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Parcetamol Group

The patient receives an envelope containing Paracetamol 1000 mg at the dose of 3 times / day + follow-up sheet + appointment card.

Drug: paracetamol
21 pills of Paracetamol 1000mg are provided with a preconised dose of 1 pill 3 times per day over 7 days period

Active Comparator: Codeine Group

The patient receives an envelope containing association of Paracetamol and Codeine at the dose of 2 times /day + follow-up sheet + appointment card.

Drug: paracetamol
21 pills of Paracetamol 1000mg are provided with a preconised dose of 1 pill 3 times per day over 7 days period

Drug: Codeine
14 pills are provided with a preconised dose of 1 pill 2 times per day over 7 days period

Active Comparator: Cafeine Group

The patient receives an envelope containing association of Paracetamol and Cafeine at the dose of 2 times /day + follow-up sheet + appointment card.

Drug: paracetamol
21 pills of Paracetamol 1000mg are provided with a preconised dose of 1 pill 3 times per day over 7 days period

Drug: Caféine
14 pills are provided with a preconised dose of 1 pill 2 times per day over 7 days period
Other Names:
  • cafeine
  • Outcome Measures

    Primary Outcome Measures

    1. new oral analgesic medications needed rate at 3 days [at 3 days from discharge]

      oral analgesic medications other than those of the protocol prescribed by the treating physicians or taken by patients' own volition

    2. new oral analgesic medications needed rate at 7 days [at 7 days from discharge]

      oral analgesic medications other than those of the protocol prescribed by the treating physicians or taken by patients' own volition

    Secondary Outcome Measures

    1. the between-group difference in mean change in VNS score measured from ED discharge (VNS D0) to 7 days later [at 7 days from discharge]

      delta VNS= (VNS D0 - VNS D7 / VNS D0) x 100

    2. The appearance of side effects [at 7 days from discharge]

      The appearance of side effects: such as Drowsiness ,Decreased respiratory rate (<14 c / min), Cutaneous rash, Vomiting,Nausea,pruritus, Dizziness. • Digestive hemorrhage.

    3. the rate of ED readmissions for residual pain [at 3 days from discharge]

      ED readmissions for residual pain

    4. the rate of ED readmissions for residual pain at 7 days [at 7 days from discharge]

      ED readmissions for residual pain

    5. patient satisfaction assessed by Likert's verbal scale at 3 days [at 3 days from discharge]

      patient satisfaction assessed by Likert's verbal scale.

    6. patient satisfaction assessed by Likert's verbal scale at 7 days [at 7 days from discharge]

      patient satisfaction assessed by Likert's verbal scale.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    • Pregnancy

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nouira Semir Monastir Tunisia 5000

    Sponsors and Collaborators

    • University of Monastir

    Investigators

    • Principal Investigator: Nouira Semir, Monastir University Hospital, Monastir, Tunisia, 5000

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pr. Semir Nouira, PROFESSOR, University of Monastir
    ClinicalTrials.gov Identifier:
    NCT05229965
    Other Study ID Numbers:
    • Codeine-Cafeine-Paracetamol
    First Posted:
    Feb 8, 2022
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pr. Semir Nouira, PROFESSOR, University of Monastir
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 10, 2022