PAracetamol and NSAID in Combination: A Randomised, Blinded, Parallel, 4-group Clinical Trial
Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Daniel Hägi-Pedersen
Collaborator:
Copenhagen Trial Unit, Center for Clinical Intervention Research