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. 2018 Jun 13;19(1):318.
doi: 10.1186/s13063-018-2705-5.

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

Gerdien A Zeilmaker-Roest  1   2 , Joost van Rosmalen  3 , Monique van Dijk  4 , Erik Koomen  5 , Nicolaas J G Jansen  5 , Martin C J Kneyber  6 , Sofie Maebe  7 , Greet van den Berghe  7 , Dirk Vlasselaers  7 , Ad J J C Bogers  8 , Dick Tibboel  4 , Enno D Wildschut  4
Affiliations

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

Gerdien A Zeilmaker-Roest et al. Trials. .

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.

Trial registration: Dutch Trial Registry ( www.trialregister.nl ): NTR5448 on September 1, 2015. Institutional review board approval (MEC2015-646), current protocol version: July 3, 2017.

Keywords: Pain, Sedation, Opioids, Children, Intensive care, Cardiac surgery, PK, PD.

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Conflict of interest statement

Ethics approval and consent to participate

The study is approved by the institutional research board of the Erasmus MC (registration MEC2015–646). This study is registered at CCMO (Central Committee on Research Involving Human Subjects) (NL 53085.078.15) and EudraCT (2015–001835-20). Written informed consent from parents is obtained for every study participant.

Consent for publication

All images used in the Additional file 2 (“Short patient information flyer”) are stock images acquired by the Erasmus MC, Department of Cardiothoracic Surgery.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
SPIRIT figure Pediatric Analgesia after Cardiac Surgery (PACS) study
See this image and copyright information in PMC

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