Paracetamol Vs Caffeine Vs Codeine in the Management of Post Traumatic Pain in Emergencies
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
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:
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Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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.
- the rate of ED readmissions for residual pain [at 3 days from discharge]
ED readmissions for residual pain
- the rate of ED readmissions for residual pain at 7 days [at 7 days from discharge]
ED readmissions for residual pain
- patient satisfaction assessed by Likert's verbal scale at 3 days [at 3 days from discharge]
patient satisfaction assessed by Likert's verbal scale.
- 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
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.
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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
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acute /history of GI hemorrhage and renal insufficiency,
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an inability to assess pain intensity according to the VNS.
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Pregnancy
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heart failure
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known hepatic cirrhosis
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known severe renal impairment (Creatinine clearance <30 ml/min)
-
swallowing disorders
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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.- Codeine-Cafeine-Paracetamol