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