Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by The University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01065701
First received: February 7, 2010
Last updated: February 8, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Patient Between 1-8 Years Old Undergoing Elective Surgery at Queen Mary Hospital
Drug: Dexmedetomidine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children - a Double-blinded Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • proportion of children attained satisfactory sedation [ Time Frame: one hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to onset of sedation [ Time Frame: one hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: July 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Year to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01065701

Contacts
Contact: Vivian M Yuen, MBBS 853 93034274 ext -- vtang131@hku.hk

Locations
Hong Kong
QUeen Mary Hospital Recruiting
Hong Kong, Hong Kong
Principal Investigator: Vivian M Yuen, MBBS         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Vivian M Yuen, MBBS Associate Consultant, Queen Mary Hospital
  More Information

No publications provided

Responsible Party: Dr. Vivian Man-ying YUEN, Queen Mary Hospital
ClinicalTrials.gov Identifier: NCT01065701     History of Changes
Other Study ID Numbers: InDex3
Study First Received: February 7, 2010
Last Updated: February 8, 2010
Health Authority: Hong Kong: Ethics Committee

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014