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Melatonin Premedication in Children Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT02265822
Recruitment Status : Completed
First Posted : October 16, 2014
Last Update Posted : October 16, 2014
Sponsor:
Collaborators:
Eloisa Gitto
Lucia Marseglia
Gabriella D'Angelo
Sara Manti
Simona Montalto
Pietro Impellizzeri
Information provided by (Responsible Party):
Carmelo Romeo MD, MSc, Azienda Ospedaliera Universitaria Policlinico

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.


Condition or disease Intervention/treatment Phase
Premedication Anaesthesia Drug: melatonin in children premedication Drug: midazolam in children premedication Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Effects of Melatonin on Preoperative Anxiety and Postoperative Analgesia in Children Undergoing Surgery: a Prospective, Randomized Clinical Trial
Study Start Date : September 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: melatonin
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
Active Comparator: midazolam
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



Primary Outcome Measures :
  1. efficacy of melatonin as premedicant in children undergoing elective surgery [ Time Frame: day 1: 40-45 min after melatonin or midazolam premedication ]
    the required infusion of propofol required during induction of general anaesthesia in both groups will be evaluated


Secondary Outcome Measures :
  1. effect of melatonin premedication in postoperative analgesia in children undergoing elective surgery [ Time Frame: day 1: 40 min after melatonin or midazolam premedication ]
    The child's level of sedation will be assessed and recorded using the University of Michigan Sedation Scale (UMSS).

  2. effect of melatonin premedication in postoperative analgesia in children undergoing elective surgery [ Time Frame: day 1: 3, 6, and 12 hours post surgery ]
    post procedural pain will be assessed and recorded in both groups



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Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265822


Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Eloisa Gitto
Lucia Marseglia
Gabriella D'Angelo
Sara Manti
Simona Montalto
Pietro Impellizzeri
Investigators
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Study Chair: Carmelo Romeo, Prof Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Publications of Results:
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Responsible Party: Carmelo Romeo MD, MSc, Professor, Azienda Ospedaliera Universitaria Policlinico
ClinicalTrials.gov Identifier: NCT02265822    
Other Study ID Numbers: 797/2012
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014
Keywords provided by Carmelo Romeo MD, MSc, Azienda Ospedaliera Universitaria Policlinico:
melatonin
midazolam
children
Additional relevant MeSH terms:
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Midazolam
Melatonin
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents