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Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children

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ClinicalTrials.gov Identifier: NCT01065701
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
YUEN, Vivian Man-ying, The University of Hong Kong

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Patient Between 1-8 Years Old Undergoing Elective Surgery at Queen Mary Hospital Drug: Dexmedetomidine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. proportion of children attained satisfactory sedation [ Time Frame: one hour ]

Secondary Outcome Measures :
  1. time to onset of sedation [ Time Frame: one hour ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   1 Year to 8 Years   (Child)
Sexes Eligible for Study:   All
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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): NCT01065701


Locations
Hong Kong
QUeen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Vivian M Yuen, MBBS Associate Consultant, Queen Mary Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: YUEN, Vivian Man-ying, Dr., The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01065701     History of Changes
Other Study ID Numbers: InDex3
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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