Melatonin Premedication in Children Undergoing Surgery

Anaesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265822
• Other study ID #: 797/2012
• Status: Completed
• Phase: Phase 4
• First received: October 7, 2014
• Last updated: October 15, 2014
• Start date: September 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2014
• Source: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Anaesthesia
• Premedication

Intervention

Drug:
• melatonin in children premedication

• midazolam in children premedication

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Policlinico "G. Martino"	Eloisa Gitto, Gabriella D’Angelo, Lucia Marseglia, Pietro Impellizzeri, Sara Manti, Simona Montalto

References & Publications (4)

Acil M, Basgul E, Celiker V, Karagöz 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. — View 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. — View Citation

Naguib M, Gottumukkala V, Goldstein PA. Melatonin and anesthesia: a clinical perspective. J Pineal Res. 2007 Jan;42(1):12-21. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	day 1: 40-45 min after melatonin or midazolam premedication
Secondary	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).	day 1: 40 min after melatonin or midazolam premedication
Secondary	effect of melatonin premedication in postoperative analgesia in children undergoing elective surgery	post procedural pain will be assessed and recorded in both groups	day 1: 3, 6, and 12 hours post surgery