Clinical Trial: A Comparison of Two Doses of Intranasal Dexmedetomidine for Premedication in Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Comparison of Two Doses of Intranasal Dexmedetomidine for Premedication in Children - a Double- Blind Randomised Controlled Trial

Brief Summary: The purpose of the study is to determine if 4mcg/kg of intranasal dexmedetomidine is better than 2mcg/kg in successfully sedating a child prior to induction of anesthesia.

Detailed Summary:

Dexmedetomidine is a selective alpha-2 adrenoreceptor agonist that has sedative, anxiolytic and analgesic properties without causing respiratory depression. It has been administered safely and effectively via a number of routes including as an intravenous infusion, intramuscularly, intranasally, buccally and orally .

Yuen et al established that the median time of onset of sedation is 25-30 minutes, making it an ideal agent for preoperative sedation. The same group also studied doses of 1 mcg/kg and 2 mcg/kg as a sedative premedication and found that the success rates of appropriate sedation at induction in children aged 1 to 8 years were 53% and 66% respectively, with a dose related increase in successful sedation.

Much higher doses of dexmedetomidine have also been used safely. Administered intravenously, 3mcg/kg of dexmedetomidine has been shown to provide satisfactory sedation for paediatric MRI in 97% of cases, without adverse effects.

The investigators aim to show that high dose intranasal dexmedetomidine is a safe, effective and an easily administered sedative premedication.

The investigators hypothesise that 4mcg/kg compared to 2mcg/kg of intranasal dexmedetomidine will lead to at least a 20% increase in the proportion of satisfactorily sedated patients at the time of anaesthesia induction.

The primary outcome will be the proportion of children with satisfactory sedation at the time of anaesthesia induction.

Suitable patients will be identified from the theatre lists and consent will be sought from their legal guardians during preassessment clinic or during their anaesthetic preoperative assessment on the ward.

Sponsor: The University of Hong Kong

Current Primary Outcome: Satisfactory sedation [ Time Frame: From 30 minutes post drug administration to induction of anaesthesia (average 30 minutes) ]

The primary outcome will be the proportion of children with satisfactory sedation at the time of anaesthesic induction.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to satisfactory sedation [ Time Frame: From time of drug administration to when Observer's Assessment of Alertness/ Sedation Score is 2 or less (from 0 minutes to 30 minutes) ]
    Time taken from drug administration to when the child's sedation level is that of only responding after mild prodding or shaking
  • Blood pressure [ Time Frame: From drug administration to end of anaesthesia (on average 1 to 3 hours) ]
    Blood pressure will be taken every 5 minutes
  • Heart rate [ Time Frame: From drug administration to end of anaesthesia (on average 1 to 3 hours) ]
    Heart rate will be taken every 5 minutes
  • Oxygen saturations [ Time Frame: From drug administration to end of anaesthesia (on average 1 to 3 hours) ]
    Oxygen saturations will be taken every 5 minutes


Original Secondary Outcome: Same as current

Information By: The University of Hong Kong

Dates:
Date Received: May 20, 2015
Date Started: June 2015
Date Completion: May 2016
Last Updated: April 15, 2016
Last Verified: April 2016