This is a a multi-center randomized controlled trial in children aged 0-36 months after cardiac surgery..Morphine is worldwide the analgesic of first choice after cardiac surgery in children. Morphine hasunwanted hemodynamic and respiratory side effects. Therefore, post–cardiac surgery patients may potentiallybenefit from a non-opioid drug for pain relief.The aim of the study is to test the hypothesis that intermittent IV paracetamol administration in children after cardiac surgery will result in a reduction of at least 30% of the cumulative morphine requirement in the first 48 hours.This is a prospective, multi-center, randomized controlled trial at four level-3 pediatric intensive care units(ICUs) in the Netherlands and Belgium. Children who are 0–36 months old are randomly assigned toreceive either intermittent IV paracetamol or continuous IV morphine up to 48 h post-operatively. Morphinewill be available as rescue medication for both groups. Validated pain and sedation assessment tools will beused to monitor patients. The sample size (n = 208, 104 per arm) was calculated in order to detect a 30%reduction in morphine dose; two-sided significance level was 5% and power was 95%.

Date Submitted: 2023-04-06