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OpenTrials
Completed

NCT Number: NCT01065701

Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children

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.

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Key information

Conditions

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

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

QUeen Mary Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Intranasal dexmedetomidine is given as premedication prior to induction of anesthesia

Primary outcomes

  1. proportion of children attained satisfactory sedation

    Time frame: one hour

Secondary outcomes

  1. time to onset of sedation

    Time frame: one hour

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 9, 2010
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.