Clinical trial NCT03222518: NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management
Official title: NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain Due to Trauma
Keywords: acute pain, trauma, paracetamol, NSAID
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects are randomized in 3 arms:

* paracetamol group
* NSAID group
* paracetamol + NSAID group
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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.
* 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 NSAIDs,
* contraindication to paracetamol or NSAIDs,
* 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

Primary outcomes:
measure: new oral analgesic medications needed rate
timeFrame: 3 days and 7 days
Secondary outcomes:
measure: the between-group difference in mean change in VNS score measured from ED discharge (VNS D0) to 7 days later
timeFrame: 3 and 7 days
measure: The appearance of side effects
timeFrame: 7 days
measure: the rate of ED readmissions for residual pain
timeFrame: 3 and 7 days
measure: patient satisfaction assessed by Likert's verbal scale.
timeFrame: 3 and 7 days
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Monastir University Hospital
Study officials:
affiliation: University of Monastir
name: Semir Nouira, MD
role: PRINCIPAL_INVESTIGATOR
References: