Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children

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

Official title:

Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children - a Double-blinded Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065701
• Other study ID #: InDex3
• Status: Completed
• Phase: Phase 3
• First received: February 7, 2010
• Last updated: October 24, 2017
• Start date: July 2009
• Est. completion date: August 2010

Study information

• Verified date: October 2017
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Dexmedetomidine
Intranasal dexmedetomidine is given as premedication prior to induction of anesthesia

Locations

Country	Name	City	State
Hong Kong	QUeen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of children attained satisfactory sedation		one hour
Secondary	time to onset of sedation		one hour