Clinical trial NCT02265822: Melatonin Premedication in Children Undergoing Surgery
Official title: Assessment of the Effects of Melatonin on Preoperative Anxiety and Postoperative Analgesia in Children Undergoing Surgery: a Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Premedication
Anaesthesia
Keywords: melatonin
midazolam
children
Lead sponsor: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Sponsor class: OTHER
Collaborators: name: Eloisa Gitto
name: Lucia Marseglia
name: Gabriella D'Angelo
name: Sara Manti
name: Simona Montalto
name: Pietro Impellizzeri
First posted: 2014-10-16
Enrollment: 92
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

- Children between the age of 5 and 14 years scheduled for elective surgery

Exclusion Criteria:

* 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

Primary outcomes:
measure: efficacy of melatonin as premedicant in children undergoing elective surgery
timeFrame: day 1: 40-45 min after melatonin or midazolam premedication
Secondary outcomes:
measure: effect of melatonin premedication in postoperative analgesia in children undergoing elective surgery
timeFrame: day 1: 40 min after melatonin or midazolam premedication
measure: effect of melatonin premedication in postoperative analgesia in children undergoing elective surgery
timeFrame: day 1: 3, 6, and 12 hours post surgery
Other outcomes:
Locations:
Study officials:
affiliation: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
name: Carmelo Romeo, Prof
role: STUDY_CHAIR
References:
citation: Acil M, Basgul E, Celiker V, Karagoz AH, Demir B, Aypar U. Perioperative effects of melatonin and midazolam premedication on sedation, orientation, anxiety scores and psychomotor performance. Eur J Anaesthesiol. 2004 Jul;21(7):553-7. doi: 10.1017/s0265021504007094.
citation: Naguib M, Gottumukkala V, Goldstein PA. Melatonin and anesthesia: a clinical perspective. J Pineal Res. 2007 Jan;42(1):12-21. doi: 10.1111/j.1600-079X.2006.00384.x.
citation: Naguib M, Samarkandi AH, Moniem MA, Mansour Eel-D, Alshaer AA, Al-Ayyaf HA, Fadin A, Alharby SW. The effects of melatonin premedication on propofol and thiopental induction dose-response curves: a prospective, randomized, double-blind study. Anesth Analg. 2006 Dec;103(6):1448-52. doi: 10.1213/01.ane.0000244534.24216.3a.
citation: Kurdi MS, Patel T. The role of melatonin in anaesthesia and critical care. Indian J Anaesth. 2013 Mar;57(2):137-44. doi: 10.4103/0019-5049.111837.