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Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children

NCT ID: NCT01065701

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Patient Between 1-8 Years Old Undergoing Elective Surgery at Queen Mary Hospital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1mcg/kg

1mcg/kg intranasal dexmedetomidine administered 45 minutes befoe anesthesia induction

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Intranasal dexmedetomidine is given as premedication prior to induction of anesthesia

2mcg/kg

2mcg/kg intranasal dexmedetomidine given 45 minutes prior to anesthetic induction

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Intranasal dexmedetomidine is given as premedication prior to induction of anesthesia

Interventions

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Dexmedetomidine

Intranasal dexmedetomidine is given as premedication prior to induction of anesthesia

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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YUEN, Vivian Man-ying

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vivian M Yuen, MBBS

Role: PRINCIPAL_INVESTIGATOR

Associate Consultant, Queen Mary Hospital

Locations

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QUeen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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InDex3

Identifier Type: -

Identifier Source: org_study_id