Abstract | BACKGROUND:
Emergence agitation and delirium in children remain a common clinical challenge in the post- anesthetic care unit. Preoperative oral melatonin has been suggested as an effective preventive drug with a favorable safety profile. The oral bioavailability of melatonin, however, is low. Therefore, the MELA-PAED trial aims to investigate the efficacy and safety of intraoperative intravenous melatonin for the prevention of emergence agitation in pediatric surgical patients. METHODS: MELA-PAED is a randomized, double-blind, parallel two-arm, multi-center, superiority trial comparing intravenous melatonin with placebo. Four hundred participants aged 1-6 years will be randomized 1:1 to either the intervention or placebo. The intervention consists of intravenous melatonin 0.15 mg/kg administered approximately 30 min before the end of surgery. Participants will be monitored in the post- anesthetic care unit (PACU), and the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) will be performed on days 1, 7, and 14 after the intervention. Serious Adverse Events (SAE) will be assessed up to 30 days after the intervention. RESULTS: CONCLUSION:
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Authors | Anne Louise de Barros Garioud, Lars Peter Kloster Andersen, Aksel Karl Georg Jensen, Hien Quoc Do, Janus Christian Jakobsen, Lars Broksø Holst, Lars Simon Rasmussen, Arash Afshari |
Journal | Acta anaesthesiologica Scandinavica
(Acta Anaesthesiol Scand)
(Oct 30 2023)
ISSN: 1399-6576 [Electronic] England |
PMID | 37904610
(Publication Type: Journal Article)
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Copyright | © 2023 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation. |