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
Recruitment status was Recruiting
Sponsor:
The University of Hong Kong
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
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:
Further study details as provided by The University of Hong Kong:
Primary Outcome Measures:
- proportion of children attained satisfactory sedation [ Time Frame: one hour ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- time to onset of sedation [ Time Frame: one hour ] [ Designated as safety issue: No ]
| 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) |
| Genders Eligible for Study: | Both |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01065701
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 |
| Health Authority: | Hong Kong: Ethics Committee |
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 30, 2016