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Melatonin Premedication in Children Undergoing Surgery

NCT02265822 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2014-10-16

No results posted yet for this study

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

Interventions

DRUG

melatonin in children premedication

DRUG

midazolam in children premedication

Sponsors & Collaborators

  • Eloisa Gitto

    collaborator UNKNOWN

  • Lucia Marseglia

    collaborator UNKNOWN

  • Gabriella D'Angelo

    collaborator UNKNOWN

  • Sara Manti

    collaborator UNKNOWN

  • Simona Montalto

    collaborator UNKNOWN

  • Pietro Impellizzeri

    collaborator UNKNOWN

  • Azienda Ospedaliera Universitaria Policlinico "G. Martino"

    lead OTHER

Principal Investigators

  • Carmelo Romeo, Prof · Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-10-31
Completion
2013-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02265822 on ClinicalTrials.gov