Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children

The University of Hong Kong (HKU)

Status and phase: Completed; Phase 3

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

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01065701

InDex3

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 1 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups

1mcg/kg

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine

2mcg/kg

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine