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

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
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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
|
- proportion of children attained satisfactory sedation [ Time Frame: one hour ]
- time to onset of sedation [ Time Frame: one hour ]

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Ages Eligible for Study: | 1 Year to 8 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Hong Kong | |
QUeen Mary Hospital | |
Hong Kong, Hong Kong |
Principal Investigator: | Vivian M Yuen, MBBS | Associate Consultant, Queen Mary Hospital |
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 |