Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

History of Changes

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 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

Resource links provided by NLM:

Drug Information available for: Dexmedetomidine

U.S. FDA Resources

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

Primary Outcome Measures:

proportion of children attained satisfactory sedation [ Time Frame: one hour ]

Secondary Outcome Measures:

time to onset of sedation [ Time Frame: one hour ]


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 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts


Contact: Vivian M Yuen, MBBS	853 93034274	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


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

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

ClinicalTrials.gov processed this record on September 21, 2017

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