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Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01065701
Enrollment
104
Registered
2010-02-09
Start date
2009-07-31
Completion date
2010-08-31
Last updated
2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DRUGDexmedetomidine

Intranasal dexmedetomidine is given as premedication prior to induction of anesthesia

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Years to 8 Years
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

Design outcomes

Primary

MeasureTime frame
proportion of children attained satisfactory sedationone hour

Secondary

MeasureTime frame
time to onset of sedationone hour

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026