Melatonin Premedication in Children Undergoing Surgery
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|ClinicalTrials.gov Identifier: NCT02265822|
Recruitment Status : Completed
First Posted : October 16, 2014
Last Update Posted : October 16, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Premedication Anaesthesia||Drug: melatonin in children premedication Drug: midazolam in children premedication||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Assessment of the Effects of Melatonin on Preoperative Anxiety and Postoperative Analgesia in Children Undergoing Surgery: a Prospective, Randomized Clinical Trial|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
0.5 mg/kg (max 20 mg) oral melatonin premedication will be administered approximately 40 min before the induction of general anaesthesia with propofol. The melatonin will be prepared in a fixed volume of 5 ml adding water in a syringe without needle.
Drug: melatonin in children premedication
Active Comparator: midazolam
0.5 mg/kg (max 20 mg) oral midazolam premedication will be administered approximately 40 min before the induction of general anaesthesia with propofol. The melatonin will be prepared in a fixed volume of 5 ml adding 5% dextrose in a syringe without needle.
Drug: midazolam in children premedication
- efficacy of melatonin as premedicant in children undergoing elective surgery [ Time Frame: day 1: 40-45 min after melatonin or midazolam premedication ]the required infusion of propofol required during induction of general anaesthesia in both groups will be evaluated
- effect of melatonin premedication in postoperative analgesia in children undergoing elective surgery [ Time Frame: day 1: 40 min after melatonin or midazolam premedication ]The child's level of sedation will be assessed and recorded using the University of Michigan Sedation Scale (UMSS).
- effect of melatonin premedication in postoperative analgesia in children undergoing elective surgery [ Time Frame: day 1: 3, 6, and 12 hours post surgery ]post procedural pain will be assessed and recorded in both groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265822
|Study Chair:||Carmelo Romeo, Prof||Azienda Ospedaliera Universitaria Policlinico "G. Martino"|