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NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management

Sponsor
University of Monastir (Other)
Overall Status
Completed
CT.gov ID
NCT03222518
Collaborator
(none)
1,500
Enrollment
1
Location
3
Arms
20
Actual Duration (Months)
74.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
1500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Subjects are randomized in 3 arms: paracetamol group NSAID group paracetamol + NSAID groupSubjects are randomized in 3 arms:paracetamol group NSAID group paracetamol + NSAID group
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
study medications consists of identical shape pills of each study medication randomization is made by sealed envelops and a randomly sequence generated numbers. patients and the research associate who collected the outcome data are blinded from the study group
Primary Purpose:
Treatment
Official Title:
NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Nov 1, 2018

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

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

    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. new oral analgesic medications needed rate [3 days and 7 days]

      oral analgesic medications other than those of the protocol prescribed by the treating physicians or taken by patients' own volition

    Secondary Outcome Measures

    1. the between-group difference in mean change in VNS score measured from ED discharge (VNS D0) to 7 days later [3 and 7 days]

      [delta VNS= (VNS D0 - VNS D7 / VNS D0) x 100]

    2. The appearance of side effects [7 days]

      The appearance of side effects: such as Drowsiness ,Decreased respiratory rate (<14 c / min), Cutaneous rash, Vomiting,Nausea,pruritus, Dizziness. • Digestive hemorrhage.

    3. the rate of ED readmissions for residual pain [3 and 7 days]

      ED readmissions for residual pain

    4. patient satisfaction assessed by Likert's verbal scale. [3 and 7 days]

      patient satisfaction assessed by Likert's verbal scale.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Monastir University Hospital Monastir Tunisia 5000

    Sponsors and Collaborators

    • University of Monastir

    Investigators

    • Principal Investigator: Semir Nouira, MD, University of Monastir

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pr. Semir Nouira, Professor, University of Monastir
    ClinicalTrials.gov Identifier:
    NCT03222518
    Other Study ID Numbers:
    • PAR vs NSAIDs vs Comb in Pain
    First Posted:
    Jul 19, 2017
    Last Update Posted:
    Sep 30, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Pr. Semir Nouira, Professor, University of Monastir
    acute pain, trauma, paracetamol, NSAID
    Additional relevant MeSH terms:
    Acute Pain
    Acetaminophen
    Anti-Inflammatory Agents, Non-Steroidal
    Piroxicam

    Study Results

    No Results Posted as of Sep 30, 2020