NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management

NCT03222518 | Completed Phase 3 DMC

• 1 other identifier: PAR vs NSAIDs vs Comb in Pain
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain Due to Trauma

Keywords

acute pain, trauma, paracetamol, NSAID

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• the between-group difference in mean change in VNS score measured from ED discharge (VNS D0) to 7 days later

  3 and 7 days

• The appearance of side effects

  7 days

• the rate of ED readmissions for residual pain

  3 and 7 days

• patient satisfaction assessed by Likert's verbal scale.

  3 and 7 days

Study Arms (3)

Parcetamol Group

ACTIVE COMPARATOR

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

Drug: NSAID; Drug: paracetamol-NSAID

NSAID Group

ACTIVE COMPARATOR

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

Drug: Paracetamol; Drug: paracetamol-NSAID

NSAID + Paracetamol Group

ACTIVE COMPARATOR

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; Drug: NSAID

Interventions

Paracetamol DRUG

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

NSAID + Paracetamol Group; NSAID Group

NSAID DRUG

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

Also known as: piroxicam

NSAID + Paracetamol Group; Parcetamol Group

paracetamol-NSAID 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

Also known as: combination

NSAID Group; Parcetamol Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Monastir University Hospital

Monastir, 5000, Tunisia

Location

MeSH Terms

Conditions

Acute Pain; Wounds and Injuries

Interventions

Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Piroxicam

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Semir Nouira, MD

  University of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Subjects are randomized in 3 arms: * paracetamol group * NSAID group * paracetamol + NSAID group

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: July 19, 2017
• Study Start: March 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)