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Intermittent intravenous paracetamol versus continuous morphine in infants undergoing cardiothoracic surgery: a multi-center randomized controlled trial.
- Source :
-
Critical care (London, England) [Crit Care] 2024 Apr 30; Vol. 28 (1), pp. 143. Date of Electronic Publication: 2024 Apr 30. - Publication Year :
- 2024
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Abstract
- 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.<br />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%.<br />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 Fourteen of the enrolled 208 children were withdrawn from the study before start of study medication leaving 194 patients for final analysis.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; Pā<ā0.001). The rescue morphine consumption was similar between the groups (pā=ā0.38). 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%).<br />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.<br /> (© 2024. The Author(s).)
- Subjects :
- Humans
Male
Female
Infant
Double-Blind Method
Pain, Postoperative drug therapy
Analgesics, Opioid administration & dosage
Analgesics, Opioid therapeutic use
Belgium
Netherlands
Infant, Newborn
Administration, Intravenous
Cardiac Surgical Procedures methods
Child, Preschool
Analgesics, Non-Narcotic administration & dosage
Analgesics, Non-Narcotic therapeutic use
Intensive Care Units, Pediatric organization & administration
Intensive Care Units, Pediatric statistics & numerical data
Pain Measurement methods
Morphine therapeutic use
Morphine administration & dosage
Acetaminophen therapeutic use
Acetaminophen administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1466-609X
- Volume :
- 28
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Critical care (London, England)
- Publication Type :
- Academic Journal
- Accession number :
- 38689310
- Full Text :
- https://doi.org/10.1186/s13054-024-04905-3