TY - JOUR
T1 - Intravenous morphine versus intravenous paracetamol after cardiac surgery in neonates and infants
T2 - A study protocol for a randomized controlled trial
AU - Zeilmaker-Roest, Gerdien A.
AU - van Rosmalen, Joost
AU - van Dijk, Monique
AU - Koomen, Erik
AU - Jansen, Nicolaas J.G.
AU - Kneyber, Martin C.J.
AU - Maebe, Sofie
AU - van den Berghe, Greet
AU - Vlasselaers, Dirk
AU - Bogers, Ad J.J.C.
AU - Tibboel, Dick
AU - Wildschut, Enno D.
N1 - Funding Information:
This study is funded by ZonMw, “effective, efficient, safer use of medicines” project (project number 836041016), and the Sophia Foundation for Scientific Research (SSWO) (project number S16–08). Funders had no role in study design or study proceedings, writing of the report, or the decision to submit the report for publication.
Publisher Copyright:
© 2018 The Author(s).
PY - 2018/6/13
Y1 - 2018/6/13
N2 - 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.
AB - 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.
KW - Pain, Sedation, Opioids, Children, Intensive care, Cardiac surgery, PK, PD
UR - http://www.scopus.com/inward/record.url?scp=85048478806&partnerID=8YFLogxK
U2 - 10.1186/s13063-018-2705-5
DO - 10.1186/s13063-018-2705-5
M3 - Article
C2 - 29895289
AN - SCOPUS:85048478806
SN - 1745-6215
VL - 19
JO - Trials
JF - Trials
IS - 1
M1 - 318
ER -