A Phase 4 interventional study of melatonin in children premedication and midazolam in children premedication in Premedication and Anaesthesia, sponsored by Azienda Ospedaliera Universitaria Policlinico "G. Martino". Completed. Open to participants aged 5 Years to 14 Years. Per ClinicalTrials.gov, last updated 2014-10-16.
Sponsored by Azienda Ospedaliera Universitaria Policlinico "G. Martino" · Phase 4, Interventional, and Treatment
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.
Children between the age of 5 and 14 years scheduled for elective surgery will be prospectively enrolled between September 2012 and October 2013. A physician will perform the clinical examination for each child, and anamnestic data will be collected in the medical records. Exclusion criteria will be: patients who had taken benzodiazepines, opioid drugs, or other sedative in the previous month; those who had sedation previously, or those with a temperament disorder, patients undergoing emergency surgery. Patients will be randomly assigned to 2 groups based on whether they will receive 0.2 mg/kg (max 5 mg) oral melatonin premedication (group A) or 0.5 mg/kg (max 20 mg) oral midazolam premedication (group B) before induction anaesthesia with propofol. For elective surgery, premedication will be performed between 07:30 and 09:30 h. Approximately 40 min before the induction of general anaesthesia, patients will be transported in a quiet room in the operating suite where they will receive orally melatonin or midazolam. The melatonin will be prepared by a dedicated resident in a fixed volume of 5 ml adding water in a syringe without needle. To simulate the sweet taste of the formulation of melatonin used, midazolam will be expanded to the fixed volume with 5% dextrose. The content of the syringe, in both cases marked with a coded label, will be blindly administrated to patients by the attendant nurse, not involved in the study. The child's level of sedation will be assessed and recorded by a resident before the premedication and 40 min after the administration of melatonin or midazolam, using the University of Michigan Sedation Scale (UMSS). In the operating room, an initial bolus dose of 1 mg/kg of intravenous propofol will be administered to both groups, followed by similar bolus doses of propofol until the patient will be anesthetized. Children will be considered anesthetized when asleep and not arousable. Anaesthesia will be maintained with inhalated sevoflurane. The total dose of propofol administrated will be recorded by the anaesthetist blinded to premedication group assignment. To provide objective information on the physical condition of patients after anaesthesia, Aldrete scale will be calculated after 10 min from conclusion of anaesthesia. Preoperative anxiety and postoperative analgesia will be also assessed in both groups.
Azienda Ospedaliera Universitaria Policlinico "G. Martino" is the lead sponsor of 16 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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
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
the required infusion of propofol required during induction of general anaesthesia in both groups will be evaluated
Time frame: day 1: 40-45 min after melatonin or midazolam premedication
effect of melatonin premedication in postoperative analgesia in children undergoing elective surgery
The child's level of sedation will be assessed and recorded using the University of Michigan Sedation Scale (UMSS).
Time frame: day 1: 40 min after melatonin or midazolam premedication
effect of melatonin premedication in postoperative analgesia in children undergoing elective surgery
post procedural pain will be assessed and recorded in both groups
Time frame: day 1: 3, 6, and 12 hours post surgery
No study locations are listed for this record.
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera Universitaria Policlinico "G. Martino"