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

February 7, 2010
February 8, 2010
July 2009
June 2010   (final data collection date for primary outcome measure)
proportion of children attained satisfactory sedation [ Time Frame: one hour ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01065701 on ClinicalTrials.gov Archive Site
time to onset of sedation [ Time Frame: one hour ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Patient Between 1-8 Years Old Undergoing Elective Surgery at Queen Mary Hospital
Drug: Dexmedetomidine
Intranasal dexmedetomidine is given as premedication prior to induction of anesthesia
  • Active Comparator: 1mcg/kg
    1mcg/kg intranasal dexmedetomidine administered 45 minutes befoe anesthesia induction
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: 2mcg/kg
    2mcg/kg intranasal dexmedetomidine given 45 minutes prior to anesthetic induction
    Intervention: Drug: Dexmedetomidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
104
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
1 Year to 8 Years
No
Contact: Vivian M Yuen, MBBS 853 93034274 ext -- vtang131@hku.hk
Hong Kong
 
NCT01065701
InDex3
No
Dr. Vivian Man-ying YUEN, Queen Mary Hospital
The University of Hong Kong
Not Provided
Principal Investigator: Vivian M Yuen, MBBS Associate Consultant, Queen Mary Hospital
The University of Hong Kong
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP