NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management

NCT ID: NCT03222518

Last Updated: 2020-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-11-01

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.

Conditions

Acute Pain Due to Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Parcetamol Group

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

Group Type: ACTIVE_COMPARATOR

NSAID

Intervention Type: DRUG

14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period

paracetamol-NSAID

Intervention Type: DRUG

21 identical pills of paracetamol ith a preconised dose of 1 pill 3 times per day over 7 days period+14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period

NSAID Group

The patient receives an envelope containing NSAID 20 mg piroxicam twice daily / day + follow-up sheet + appointment card.

Group Type: ACTIVE_COMPARATOR

Paracetamol

Intervention Type: DRUG

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

paracetamol-NSAID

Intervention Type: DRUG

21 identical pills of paracetamol ith a preconised dose of 1 pill 3 times per day over 7 days period+14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period

NSAID + Paracetamol Group

The patient receives an envelope containing NSAID 20 mg piroxicam at a dose of 2 times/day + Paracetamol 1000 mg at a dose of 3 times / day + follow-up sheet + appointment card.

Group Type: ACTIVE_COMPARATOR

Paracetamol

Intervention Type: DRUG

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

NSAID

Intervention Type: DRUG

14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period

Interventions

Paracetamol

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

Intervention Type: DRUG

NSAID

14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period

Intervention Type: DRUG

paracetamol-NSAID

21 identical pills of paracetamol ith a preconised dose of 1 pill 3 times per day over 7 days period+14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period

Intervention Type: DRUG

Other Intervention Names

piroxicam; combination

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Pr. Semir Nouira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Semir Nouira, MD

Role: PRINCIPAL_INVESTIGATOR

University of Monastir

Locations

Monastir University Hospital

Monastir, , Tunisia

Countries

Tunisia

Other Identifiers

PAR vs NSAIDs vs Comb in Pain

Identifier Type: -

Identifier Source: org_study_id