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Published on: November 11, 2014
Intravenous morphine versus intravenous paracetamol after cardiac surgery in neonates and infants: a study protocol
Gerdien A Zeilmaker-Roest1,2, Joost van Rosmalen3, Monique van Dijk4
1Department of Pediatric Intensive Care, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands. g.zeilmaker@erasmusmc.nl.
Insights
This study investigates if intravenous paracetamol can reduce morphine use in children after heart surgery. Results aim to establish a new pain management guideline for infants.
Area of Science:
- Pediatric Anesthesiology
- Pain Management
- Cardiothoracic Surgery
Background:
- Morphine is the standard analgesic after pediatric cardiac surgery but has significant side effects.
- Non-opioid alternatives like intravenous paracetamol may offer a safer pain management strategy.
- Previous research indicates IV paracetamol's efficacy in non-cardiac pediatric surgery.
Purpose of the Study:
- To determine if intermittent IV paracetamol reduces morphine requirements by at least 30% in children undergoing cardiac surgery.
- To evaluate the effectiveness of IV paracetamol as an opioid-sparing agent in this population.
- To develop a new evidence-based pain management algorithm for post-cardiac surgery infants.
Main Methods:
- A prospective, multi-center, randomized controlled trial involving 208 children aged 0-36 months.
- Patients were randomized to receive either intermittent IV paracetamol or continuous IV morphine for 48 hours post-operatively.
- Morphine was available as rescue medication for both groups, with pain and sedation monitored using validated tools.
Main Results:
- The study is designed to detect a 30% reduction in cumulative morphine dose.
- Statistical power of 95% and a two-sided significance level of 5% were used for sample size calculation.
- Results will inform the development of a new pain management guideline.
Conclusions:
- This trial focuses on reducing or replacing morphine with IV paracetamol in infants post-cardiac surgery.
- Findings will support a new pain management algorithm for pediatric intensive care units.
- An evidence-based guideline for post-operative pain management in infants undergoing cardiac surgery will be established.
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.
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