Intravenous morphine versus intravenous paracetamol after cardiac surgery in neonates and infants: a study protocol for a randomized controlled trial

Gerdien A. Zeilmaker-Roest*, Joost van Rosmalen, Monique van Dijk, Erik Koomen, Nicolaas J. G. Jansen, Martin C. J. Kneyber, Sofie Maebe, Greet van den Berghe, Dirk Vlasselaers, Ad J. J. C. Bogers, Dick Tibboel, Enno D. Wildschut

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

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 0-36 months old will be randomly assigned to receive either intermittent IV paracetamol or continuous IV morphine up to 48 h 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 (0-36 months 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 0-36 months old.

Original languageEnglish
Article number318
Number of pages11
JournalTRIALS
Volume19
DOIs
Publication statusPublished - 13-Jun-2018

Keywords

  • Pain
  • Sedation
  • Opioids
  • Children
  • Intensive care
  • Cardiac surgery
  • PK
  • PD
  • ARISTOTLE COMPREHENSIVE COMPLEXITY
  • CONGENITAL HEART-DISEASE
  • CARDIOPULMONARY BYPASS
  • POSTOPERATIVE PAIN
  • ANALGESIC EFFICACY
  • NEWBORN-INFANTS
  • MAJOR SURGERY
  • YOUNG INFANTS
  • DOWN-SYNDROME
  • CHILDREN

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