Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children

Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children - a Double-blinded Randomized Controlled Trial

Intranasal dexmedetomidine has shown to be an effective sedative when used prior to anaesthetic induction as premedication. 1mcg/kg intranasal dexmedetomidine was used in previous study and it produced satisfactory sedation in more than 50% of the children at the time of anaesthetic induction with no adverse effect. In this study we aim to compare 1mcg/kg with 2mcg/kg intranasal dexmedetomidine in children. We expect more children would attain satisfactory sedation prior to anaesthetic induction when higher dose is used.

Study Overview

• Status: Completed
• Conditions: Patient Between 1-8 Years Old Undergoing Elective Surgery at Queen Mary Hospital
• Intervention / Treatment: Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 3

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 1-12 years old
• American Society of Anesthesiologists (ASA) 1-2
• Elective surgery
• Children with autism or pervasive personality disorder

Exclusion Criteria:

• American Society of Anaesthesiologists (ASA) 3-5
• Allergy or hypersensitive reaction to dexmedetomidine
• Known cardiac arrhythmia or congenital heart disease
• Mentally disabled

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1mcg/kg; 1mcg/kg intranasal dexmedetomidine administered 45 minutes befoe anesthesia induction	Drug: Dexmedetomidine; Intranasal dexmedetomidine is given as premedication prior to induction of anesthesia
Active Comparator: 2mcg/kg; 2mcg/kg intranasal dexmedetomidine given 45 minutes prior to anesthetic induction	Drug: Dexmedetomidine; Intranasal dexmedetomidine is given as premedication prior to induction of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of children attained satisfactory sedation	one hour

Secondary Outcome Measures

Outcome Measure	Time Frame
time to onset of sedation	one hour

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Vivian M Yuen, MBBS, Associate Consultant, Queen Mary Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: February 7, 2010
• First Submitted That Met QC Criteria: February 8, 2010
• First Posted (Estimate): February 9, 2010

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: InDex3