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.

Study Overview

• Status: Completed
• Conditions: Acute Pain Due to Trauma
• Intervention / Treatment: Drug: NSAID; Drug: paracetamol-NSAID; Drug: Paracetamol

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.

• Study Type: Interventional
• Enrollment (Actual): 1500
• Phase: Phase 3

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • Monastir University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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: NSAID; 14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period; Other Names: piroxicam; 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; Other Names: combination
ACTIVE_COMPARATOR: NSAID Group; The patient receives an envelope containing NSAID 20 mg piroxicam twice daily / day + follow-up sheet + appointment card.	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; Other Names: combination; 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: 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.	Drug: NSAID; 14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period; Other Names: piroxicam; Drug: Paracetamol; 21 pills of Paracetamol 1000mg are provided with a preconised dose of 1 pill 3 times per day over 7 days period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
new oral analgesic medications needed rate	oral analgesic medications other than those of the protocol prescribed by the treating physicians or taken by patients' own volition	3 days and 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the between-group difference in mean change in VNS score measured from ED discharge (VNS D0) to 7 days later	[delta VNS= (VNS D0 - VNS D7 / VNS D0) x 100]	3 and 7 days
The appearance of side effects	The appearance of side effects: such as Drowsiness ,Decreased respiratory rate (<14 c / min), Cutaneous rash, Vomiting,Nausea,pruritus, Dizziness. • Digestive hemorrhage.	7 days
the rate of ED readmissions for residual pain	ED readmissions for residual pain	3 and 7 days
patient satisfaction assessed by Likert's verbal scale.	patient satisfaction assessed by Likert's verbal scale.	3 and 7 days

Collaborators and Investigators

• Sponsor: University of Monastir

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): November 1, 2018
• Study Completion (ACTUAL): November 1, 2018

Study Registration Dates

• First Submitted: May 14, 2017
• First Submitted That Met QC Criteria: July 16, 2017
• First Posted (ACTUAL): July 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: acute pain, trauma, paracetamol, NSAID
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Piroxicam
• Other Study ID Numbers: PAR vs NSAIDs vs Comb in Pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No