PAracetamol and NSAID in Combination: A Randomised, Blinded, Parallel, 4-group Clinical Trial

Summary

Trial name: PAracetamol and NSAID in combination: A randomised, blinded, parallel, 4-group clinical trial

Trial acronym: PANSAID

Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists after total hip arthroplasty (THA) and combinations of different non-opioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy.

Objectives: The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen and their combination in different dosages after THA.

Intervention: Patients are randomised to 4 groups: A) paracetamol 1 g x 4 and ibuprofen 400 mg x 4; B) paracetamol 1 g x 4 and placebo (ibuprofen); C) placebo (paracetamol) and ibuprofen 400 mg x 4; and D) paracetamol 0,5 g x 4 and ibuprofen 200 mg.

Design: Placebo controlled, parallel 4-group, multicentre trial with adequate centralised computer-generated allocation sequence and allocation concealment with varying block size and stratification by site. Blinding of assessor, investigator, caregivers, patients, and statisticians.

Sample size: 556 eligible patients are needed to detect a difference of 10 mg morphine the first postoperative day with a standard deviation of 20 mg and a type 1 error rate of 0,004 (two-sided) and a type 2 error rate of 0,10.

Conditions

• Pain, Postoperative

Interventions

DRUG

Paracetamol (1g x 4)

Dose of 1 g given in 6 hour intervals the first 24 hours postoperatively

DRUG

Ibuprofen (400 mg x 4)

Dose of 400 mg given in 6 hour intervals the first 24 hours postoperatively

DRUG

Paracetamol (0,5 g x 4)

Dose of 0,5 g given in 6 hour intervals the first 24 hours postoperatively

DRUG

Ibuprofen (200 mg x 4)

Dose of 200 mg given in 6 hour intervals the first 24 hours postoperatively

DRUG

Placebo (x4)

Given in 6 hour intervals the first 24 hours postoperatively

Sponsors & Collaborators

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• Daniel Hägi-Pedersen

  lead OTHER

Principal Investigators

• Daniel Hägi-Pedersen, MD, PhD · Department of Anaesthesiology, Næstved Hospital

• Kasper H Thybo, MD · Department of Anaesthesiology, Næstved Hospital

• Ole Mathiesen, MD, PhD · Department of Anaesthesiology, Køge Hospital

• Jørgen B Dahl, MD, DMSc · Department of Anaesthesiology, Bispebjerg Hospital

• Jørn Wetterslev, MD, PhD · Copenhagen Trial Unit, Center for Clinical Intervention Research

• Martin Pohlman, MD · Department of Anaesthesiology, Nykøbing Falster Hospital

• Hans Henrik Bülow, MD · Department of Anaesthesiology, Holbæk Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2017-10-31

Completion

2018-01-31

Countries

• Denmark

Study Locations