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Intermittent intravenous paracetamol versus continuous morphine in infants undergoing cardiothoracic surgery: a
Gerdien Zeilmaker-Roest1,2, Christine de Vries-Rink3,4, Joost van Rosmalen5,6
1Department of Neonatal and Pediatric Intensive Care, Division of Pediatric Intensive Care, Erasmus MC-Sophia Children's Hospital, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands. g.zeilmaker@erasmusmc.nl.
Insights
Intermittent intravenous (IV) paracetamol significantly reduced morphine use by 79% in young children after heart surgery. This approach provided comparable pain relief, establishing IV paracetamol as an effective primary analgesic.
Area of Science:
- Pediatric Cardiac Surgery
- Pain Management
- Pharmacology
Background:
- Postoperative pain management in children undergoing cardiac surgery with cardiopulmonary bypass often relies on opioids.
- Morphine is a common analgesic but carries risks, necessitating exploration of alternatives.
- Optimizing pain relief while minimizing opioid exposure is crucial for pediatric recovery.
Purpose of the Study:
- To evaluate if intermittent intravenous (IV) paracetamol as a primary analgesic can decrease morphine consumption in children aged 0-3 years post-cardiac surgery.
- To compare morphine requirements between patients receiving IV paracetamol and those receiving continuous morphine.
- To assess the non-inferiority of IV paracetamol in terms of pain scores.
Main Methods:
- A multi-center, randomized, double-blinded, controlled trial was conducted in Pediatric Intensive Care Units (PICUs).
- Eligible children (0-3 years) received either continuous morphine or intermittent IV paracetamol after an initial morphine dose.
- Pain was assessed using the Numeric Rating Scale (NRS), with rescue morphine administered as needed. The primary outcome was cumulative morphine dose in the first 48 hours post-surgery.
Main Results:
- 208 children were included in the study (102 IV paracetamol, 106 continuous morphine).
- The IV paracetamol group showed a 79% reduction in median weight-adjusted cumulative morphine consumption (145.0 mcg/kg vs. 692.6 mcg/kg; P < 0.001).
- Non-inferiority was demonstrated for IV paracetamol regarding NRS pain scores, with no significant difference in the proportion of patients experiencing high pain scores.
Conclusions:
- Intermittent IV paracetamol significantly reduces morphine consumption by 79% in young children following cardiac surgery.
- IV paracetamol provides comparable pain relief to continuous morphine, establishing its role as a primary analgesic.
- This study supports the use of IV paracetamol as a safer alternative to prolonged opioid use in pediatric cardiac surgery patients.
Background:
To determine whether intermittent intravenous (IV) paracetamol as primary analgesic would significantly reduce morphine consumption in children aged 0-3 years after cardiac surgery with cardiopulmonary bypass.
Methods:
Multi-center, randomized, double-blinded, controlled trial in four level-3 Pediatric Intensive Care Units (PICU) in the Netherlands and Belgium. Inclusion period; March 2016-July 2020. Children aged 0-3 years, undergoing cardiac surgery with cardiopulmonary bypass were eligible. Patients were randomized to continuous morphine or intermittent IV paracetamol as primary analgesic after a loading dose of 100 mcg/kg morphine was administered at the end of surgery. Rescue morphine was given if numeric rating scale (NRS) pain scores exceeded predetermined cutoff values. Primary outcome was median weight-adjusted cumulative morphine dose in mcg/kg in the first 48 h postoperative. For the comparison of the primary outcome between groups, the nonparametric Van Elteren test with stratification by center was used. For comparison of the proportion of patients with one or more NRS pain scores of 4 and higher between the two groups, a non-inferiority analysis was performed using a non-inferiority margin of 20%.
Results:
In total, 828 were screened and finally 208 patients were included; parents of 315 patients did not give consent and 305 were excluded for various reasons. Fourteen of the enrolled 208 children were withdrawn from the study before start of study medication leaving 194 patients for final analysis. One hundred and two patients received intermittent IV paracetamol, 106 received continuous morphine. The median weight-adjusted cumulative morphine consumption in the first 48 h postoperative in the IV paracetamol group was 5 times lower (79%) than that in the morphine group (median, 145.0 (IQR, 115.0-432.5) mcg/kg vs 692.6 (IQR, 532.7-856.1) mcg/kg; P < 0.001). The rescue morphine consumption was similar between the groups (p = 0.38). Non-inferiority of IV paracetamol administration in terms of NRS pain scores was proven; difference in proportion - 3.1% (95% CI - 16.6-10.3%).
Conclusions:
In children aged 0-3 years undergoing cardiac surgery, use of intermittent IV paracetamol reduces the median weight-adjusted cumulative morphine consumption in the first 48 h after surgery by 79% with equal pain relief showing equipoise for IV paracetamol as primary analgesic. Trial Registration Clinicaltrials.gov, Identifier: NCT05853263; EudraCT Number: 2015-001835-20.
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