Overview

Melatonin Premedication in Children Undergoing Surgery

Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Collaborators:
Eloisa Gitto
Gabriella D'Angelo
Gabriella D’Angelo
Lucia Marseglia
Pietro Impellizzeri
Sara Manti
Simona Montalto
Treatments:
Melatonin
Midazolam
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