PACS
Trial question
Is intravenous acetaminophen superior to continuous morphine in infants undergoing cardiac surgery?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 194
194 patients (91 female, 103 male).
Inclusion criteria: children, aged 0-3 years, undergoing cardiac surgery with cardiopulmonary bypass.
Key exclusion criteria: known allergy or intolerance for paracetamol or morphine; opioids administered in the 24 hours before surgery; hepatic dysfunction prior to surgery; renal insufficiency; no informed consent.
Interventions
N=94 acetaminophen (a loading dose of 20 mg/kg, followed by a maintenance dose of 40 mg/kg/day in neonates and 60 mg/kg/day in all other patients, QID).
N=100 morphine (at a range of 3.9-16.0 mcg/kg/hr).
Primary outcome
Median weight-adjusted cumulative morphine consumption in first 48 hours postoperatively
145 mcg/kg
692.6 mcg/kg
692.6 mcg/kg
519.5 mcg/kg
346.3 mcg/kg
173.2 mcg/kg
0.0 mcg/kg
Acetaminophen
Morphine
Significant
decrease ▼
Significant decrease in median weight-adjusted cumulative morphine consumption in the first 48 hours postoperatively (145 mcg/kg vs. 692.6 mcg/kg; AD -547.6 mcg/kg, 95% CI -872.52 to -222.68).
Secondary outcomes
No significant difference in median rescue morphine total dose (29.4 mcg/kg vs. 30 mcg/kg; AD -0.6 mcg/kg, 95% CI -1.92 to 0.72).
No significant difference in median duration of postoperative mechanical ventilation (11.8 hours vs. 15.4 hours; AD -3.6 hours, 95% CI -11.69 to 4.49).
No significant difference in NRS ≥ 4 at least once (59% vs. 62%; ARD -3.1, 95% CI -16.6 to 10.3).
Safety outcomes
No significant difference in adverse events.
Conclusion
In children, aged 0-3 years, undergoing cardiac surgery with cardiopulmonary bypass, acetaminophen was superior to morphine with respect to median weight-adjusted cumulative morphine consumption in the first 48 hours postoperatively.
Reference
Gerdien Zeilmaker-Roest, Christine de Vries-Rink, Joost van Rosmalen et al. Intermittent intravenous paracetamol versus continuous morphine in infants undergoing cardiothoracic surgery: a multi-center randomized controlled trial. Crit Care. 2024 Apr 30;28(1):143.
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