The Paracetamol and NSAID in combination- PANSAID

Primary tabs

NEWS
The Paracetamol and NSAID in combination- PANSAID

Effective postoperative pain management is crucial for the rehabilitation of the surgical patient. No ‘gold standard’ approach exists after total hip arthroplasty (THA) and combinations of various nonopioid medications are employed with virtually no evidence for further analgesic efficacy as compared to monotherapy. The analgesic effects and safety of paracetamol and ibuprofen alone and in combination in different dosages after THA have been explored in the presented study.

Thybo K H and colleagues conducted a placebo-controlled, parallel four-group, multicentre trial with centralized computer-generated allocation sequence and allocation concealment along with varying block size and stratification by the site is called PANSAID. Blinding of the assessor, investigator, caregivers, patients and statisticians was done. The patients were stratified into four groups: (A) paracetamol 1g × 4 and ibuprofen 400mg × 4, (B) paracetamol 1g × 4 and placebo, (C) placebo and ibuprofen 400 mg × 4 and (D) paracetamol 0.5g × 4 and ibuprofen 200 mg. Within 90 days after the surgery, 24-h consumption of morphine and number of patients with one or more serious adverse events were depicted as the two co-primary outcomes. Pain scores during mobilisation and at rest at 6 and 24h postoperatively and the number of patients with one or more adverse events within 24h postoperatively were depicted as the secondary outcomes.

As per the inclusion criteria, the patients scheduled for unilateral, primary THA; age above 18 years; ASA status 1–3; BMI >18 and<40kg/m2; women must not be pregnant; and provision of informed consent were considered. The exclusion criteria comprised of patients who cannot cooperate with the trial; participation in another trial; patients who cannot understand/speak Danish; daily use of strong opioids; allergy against trial medication; contraindications against ibuprofen; alcohol and/or drug abuse. Five hundred and fifty-six patients were required to reveal a difference of 10 mg morphine intravenously the first 24 h postoperatively with a standard deviation of 20 mg and a family wise type 1 error rate of 0.025 (two-sided) and a type 2 error rate of 0.10 for the six possible comparisons of the four intervention groups.

Source:

Biomed central Trials

Link to the source:

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1749-7

The original title of the article:

PANSAID – PAracetamol and NSAID in combination: study protocol for a randomised trial

Authors

Kasper HøjgaardThybo et al.

Log in or register to post comments