Intravenous MELAtonin for prevention of Postoperative Agitation and Emergence Delirium in children (MELA‐PAED): A protocol and statistical analysis plan for a randomized clinical trial

Oct 31, 2023Acta anaesthesiologica Scandinavica

Using Intravenous Melatonin to Prevent Agitation and Confusion After Surgery in Children: Trial Plan and Analysis

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Abstract

Four hundred participants aged 1-6 years will be randomized to receive either intravenous melatonin or placebo during surgery.

The primary outcome will measure the incidence of emergence agitation using the Watcha score in the post-anesthetic care unit.
Secondary outcomes include monitoring opioid consumption and recording adverse events following the intervention.
Exploratory outcomes will assess serious adverse events, postoperative pain, nausea and vomiting, and recovery milestones.
The study aims to provide insights into the safety and efficacy of intravenous melatonin in preventing emergence agitation.

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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: The primary outcome is the incidence of emergence agitation, assessed dichotomously as any Watcha score >2 during the participant's stay in the post-anesthetic care unit. Secondary outcomes are opioid consumption in the post-anesthetic care unit and adverse events. Exploratory outcomes include SAEs, postoperative pain, postoperative nausea and vomiting, and time to awakening, to first oral intake, and to discharge readiness.

CONCLUSION: The MELA-PAED trial investigates the efficacy of intravenous intraoperative melatonin for the prevention of emergence agitation in pediatric surgical patients. Results may provide further knowledge concerning the use of melatonin in pediatric perioperative care.

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Intravenous MELAtonin for prevention of Postoperative Agitation and Emergence Delirium in children (MELA‐PAED): A protocol and statistical analysis plan for a randomized clinical trial

Abstract

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