Acute Pain Due to Trauma Clinical Trial
Official title:
NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management
The purpose of this study is to:
Compare the effect of paracetamol alone against NSAIDs alone against the association of
paracetamol + NSAIDs in the treatment of traumatic pain.
Paracetamol, NSAIDs, or a combination of the two molecules are usually prescribed. Patients
even use these medications without a prescription. It is not known, however, whether or not
NSAIDs have an additional value relative to paracetamol for the treatment of pain.
All patients were assigned in a 1:1:1 ratio. Randomization of subjects was 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 every 8th hour for 7 days;
NSAID group who received piroxicam 20 mg orally twice a day for 7 days, and Paracetamol-NSAID
combination who received both treatments at the same doses for 7 days. All protocol
treatments were administered in opaque packets with code number 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, and findings of the clinical examination. 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.
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