Melatonin Premedication in Children Undergoing Surgery
Condition: Premedication; Anaesthesia
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): melatonin in children premedication; midazolam in children premedication
Intervention type(s): Drug; Drug
Intervention MeSH terms: Midazolam; Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: melatonin; midazolam; children