CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 92 enrolled
Drug / intervention
melatonin in children premedication +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02265822
NCT02265822Phase 4Completed

Assessment of the Effects of Melatonin on Preoperative Anxiety and Postoperative Analgesia in Children Undergoing Surgery: a Prospective, Randomized Clinical Trial

Azienda Ospedaliera Universitaria Policlinico "G. Martino"·interventional·Posted Oct 16, 2014·Updated Oct 16, 2014

In Brief

A Phase 4 clinical trial evaluating melatonin in children premedication and midazolam in children premedication for Premedication and Anaesthesia. Completed, enrolled 92 participants.

Detailed Summary

Melatonin has been proposed as alternative to midazolam as a premedication in procedures preceding anaesthesia induction. The objective of this prospective, randomized, double-blind study is to investigate the possible effect of melatonin premedication on the required infusion of propofol in comparison to midazolam, evaluating the efficacy of oral melatonin on sedation in children undergoing surgery. Preoperative anxiety and postoperative analgesia are also assessed in both groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 16, 2014
Enrollment StartSep 1, 2012
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.7 years ago

Interventions

melatonin in children premedicationdrug

midazolam in children premedicationdrug