Intravenous morphine versus intravenous paracetamol after cardiac surgery in neonates and infants
A study protocol for a randomized controlled trial
Trials , Volume 19 - Issue 1
Background: Morphine is worldwide the analgesic of first choice after cardiac surgery in children. Morphine has unwanted hemodynamic and respiratory side effects. Therefore, post-cardiac surgery patients may potentially benefit from a non-opioid drug for pain relief. A previous study has shown that intravenous (IV) paracetamol is effective and opioid-sparing in children after major non-cardiac surgery. 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. Methods: 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 0-36months old will be randomly assigned to receive either intermittent IV paracetamol or continuous IV morphine up to 48h post-operatively. Morphine will be available as rescue medication for both groups. Validated pain and sedation assessment tools will be used 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%. Discussion: This study will focus on the reduction, or replacement, of morphine by IV paracetamol in children (0-36months old) after cardiac surgery. The results of this study will form the basis of a new pain management algorithm and will be implemented at the participating ICUs, resulting in an evidence-based guideline on post-operative pain after cardiac surgery in infants who are 0-36months old.
|Pain, Sedation, Opioids, Children, Intensive care, Cardiac surgery, PK, PD|
Zeilmaker-Roest, G.A, van Rosmalen, J.M, van Dijk, M, Koomen, E. (Erik), Jansen, N.J.G, Kneyber, M.C.J, … Wildschut, E.D. (2018). Intravenous morphine versus intravenous paracetamol after cardiac surgery in neonates and infants. Trials, 19(1). doi:10.1186/s13063-018-2705-5