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NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management

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ClinicalTrials.gov Identifier: NCT03222518
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Pr. Semir Nouira, University of Monastir

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
Acute Pain Due to Trauma Drug: Paracetamol Drug: NSAID Drug: Placebo Oral Tablet 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.

This is a prospective, randomized, double-blind, controlled study carried out in the emergency department of Monastir - Tunisia.

Four groups were individualized: Paracetamol + placebo group, NSAID + placebo group and NSAID + Paracetamol group.

All patients will receive omeprazole at a dose of 20mg / d. For each patient included, EVA, blood pressure, heart rate, respiratory rate and SaO2 were taken at admission and at the second visit after 07 days.

Otherwise, each patient will have to fill the follow-up sheet containing the measurement of EVA 3 times / day during the first 3 days of treatment at rest and during daily activity.

During the second visit, the patient has to answer the questions of satisfaction and the questionnaire EQ5D of the quality of life.

Criteria for judgment:

Main criteria:

  • Treatment success is defined as the percentage of EN ≤ 30 during the 7 days following discharge from the emergency department.
  • The patient's need to add another analgesic medication or non-pharmacological intervention.
  • Patient satisfaction with two questions on a Likert scale in 5 intensity points.
  • Improvement of the patient's quality of life according to the EQ5D questionnaire

Secondary Criteria:

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

Criteria for failure:

The following criteria were used to define treatment failure:

  • The reduction of EVA by less than 30% compared to the initial EVA.
  • The occurrence of adverse effects requiring immediate discontinuation of treatment.
  • Patient need to add another analgesic medication or non-pharmacological intervention to relieve pain.
  • Non-satisfaction of the patient according to the three questions noted in 5 points on a scale of Likert.
  • The non-improvement of the quality of life of the patient according to the questionnaire EQ5D

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Subjects are randomized in 3 arms:

  • paracetamol + placebo group
  • NSAID + placebo group
  • paracetamol + NSAID group
Masking: Double (Participant, Care Provider)
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, physicians and nurses 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 : August 1, 2016
Estimated Primary Completion Date : August 1, 2017
Estimated Study Completion Date : August 1, 2018

Arm Intervention/treatment
Active Comparator: Parcetamol + Placebo Group
The patient receives an envelope containing Paracetamol 1000 mg + a placebo at the 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: Placebo Oral Tablet
21 identical pills of Placebo are provided with a preconised dose of 1 pill 3 times per day over 7 days period

Active Comparator: NSAID + Placebo Group
The patient receives an envelope containing NSAID 50 mg + a placebo in 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: Placebo Oral Tablet
21 identical pills of Placebo 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 50 mg + 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
21 pills of Ketaprofen 50mg are provided with a preconised dose of 1 pill 3 times per day over 7 days period
Other Name: ketaprofen




Primary Outcome Measures :
  1. Treatment success rate in the first 7 days of follow-up [ Time Frame: 7 days ]
    Treatment success is defined as the percentage of EN ≤ 30 during the 7 days following discharge from the emergency department.

  2. Need for rescue medication [ Time Frame: 7 days ]
    Insufficient pain resolution according to the visual analoginc scale and the patient's need to add another analgesic medication or non-pharmacological intervention.

  3. Patient satisfaction [ Time Frame: 7th day ]
    Patient satisfaction with two questions on a Likert scale in 5 intensity points.

  4. quality of life [ Time Frame: 7th day ]
    Improvement of the patient's quality of life according to the EQ5D questionnaire


Secondary Outcome Measures :
  1. The appearance of side effects [ Time Frame: 7 days ]

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

    • Digestive hemorrhage.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • This study included patients over 18 years of age who require analgesia for acute pain of traumatic origin.

Exclusion Criteria:

  • refusal, disability, difficulties in consent or communication.
  • automutulation.
  • severe acute trauma, such as polytrauma, open or complicated fracture ...
  • regular previous use of paracetamol and / or NSAIDs and / or any other analgesic treatment during the 2 weeks prior to presentation.
  • Patients with chronic pain.
  • any form of previous analgesia for the same problem.
  • Any known allergy or side reaction to paracetamol, NSAIDs or Omeprazole.
  • pregnant woman.
  • Digestive hemorrhage or previous perforation following NSAID therapy.
  • Active or recurrent gastric ulcer (2 or more obvious episodes)
  • Previous exacerbation of asthma after the use of NSAIDs or acetylsalicylic acid.
  • severe heart failure
  • Hepatic cirrhosis
  • Severe renal insufficiency (Cl creat <30mL / min)
  • history of blood dysplasia or hematological abnormality, which indicates treatment.
  • the combined use of an CEI or ARA and diuretic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222518


Contacts
Contact: Semir Nouira, Professor semir.nouira@rns.tn
Contact: Malek Echeikh, MD echeikhmalek87@gmail.com

Locations
Tunisia
Monastir University Hospital Recruiting
Monastir, Tunisia, 5000
Contact: Semir Nouira, Prof.    +216 73106000 ext 1393    semir.nouira@rns.tn   
Contact: Mohamed habib Grissa, MD    +21698677343    grissa.medhabib@gmail.com   
Sponsors and Collaborators
University of Monastir

Responsible Party: Pr. Semir Nouira, Professor, University of Monastir
ClinicalTrials.gov Identifier: NCT03222518     History of Changes
Other Study ID Numbers: PAR vs NSAIDs vs Comb in Pain
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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, University of Monastir:
acute pain, trauma, paracetamol, NSAID

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents
Antirheumatic Agents