Melatonin Premedication in Children Undergoing Surgery

NCT02265822 | Completed Phase 4

• 1 other identifier: 797/2012
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Premedication; Anaesthesia

Keywords

melatonin; midazolam; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• effect of melatonin premedication in postoperative analgesia in children undergoing elective surgery

  day 1: 40 min after melatonin or midazolam premedication

• effect of melatonin premedication in postoperative analgesia in children undergoing elective surgery

  day 1: 3, 6, and 12 hours post surgery

Study Arms (2)

melatonin

EXPERIMENTAL

0.5 mg/kg (max 20 mg) oral melatonin premedication will be administered approximately 40 min before the induction of general anaesthesia with propofol. The melatonin will be prepared in a fixed volume of 5 ml adding water in a syringe without needle.

Drug: melatonin in children premedication

midazolam

ACTIVE COMPARATOR

0.5 mg/kg (max 20 mg) oral midazolam premedication will be administered approximately 40 min before the induction of general anaesthesia with propofol. The melatonin will be prepared in a fixed volume of 5 ml adding 5% dextrose in a syringe without needle.

Drug: midazolam in children premedication

Interventions

melatonin in children premedication DRUG

melatonin

midazolam in children premedication DRUG

midazolam

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico "G. Martino": lead
• Eloisa Gitto: collaborator
• Lucia Marseglia: collaborator
• Gabriella D'Angelo: collaborator
• Sara Manti: collaborator
• Simona Montalto: collaborator
• Pietro Impellizzeri: collaborator

Related Publications (4)

• 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.

  PMID: 15318468 RESULT

• 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.

  PMID: 17198534 RESULT

• 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.

  PMID: 17122221 RESULT

• 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.

  PMID: 23825812 RESULT

MeSH Terms

Interventions

Melatonin; Midazolam

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Benzodiazepines; Benzazepines

Study Officials

• Carmelo Romeo, Prof

  Azienda Ospedaliera Universitaria Policlinico "G. Martino"

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 16, 2014
• Study Start: September 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 16, 2014

Record last verified: 2014-10