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A Comparison of Two Doses of Intranasal Dexmedetomidine for Premedication in Children

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ClinicalTrials.gov Identifier: NCT02459509
Recruitment Status : Unknown
Verified April 2016 by The University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : June 2, 2015
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Anxiety, Separation Drug: Dexmedetomidine Phase 4

Detailed Description:

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.

In a previous study, 66% of children aged 1-5 years were satisfactorily sedated at the time of induction with 2 mcg/kg of intranasal dexmedetomidine. In order to find a 20% difference with 4 mcg/kg of dexmedetomidine, the investigators' sample size needs to be 140 (70 in each group), for a power of 0.8 and a 5% false positive rate.

The demographic data will be analysed by t test and chi-square test. The proportions of satisfactory sedation will be analysed by chi-square test. The onset sedation time and duration of sedation will be analysed by survival analysis. The vital signs over times will be expressed by percentage changes from baseline and estimated by mean and standard errors. A p-value<0.05 will be considered statistically significant.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Two Doses of Intranasal Dexmedetomidine for Premedication in Children - a Double- Blind Randomised Controlled Trial
Study Start Date : June 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Dexmedetomidine 2 mcg/kg
2 mcg/kg dexmedetomidine given intranasally once at least 30 minutes before anaesthetic induction
Drug: Dexmedetomidine
Either 2mcg/kg or 4mcg/kg of intranasal dexmedetomidine will be given to assess efficacy of preoperative sedation
Other Name: Precedex

Active Comparator: Dexmedetomidine 4 mcg/kg
4 mcg/kg dexmedetomidine given intranasally once at least 30 minutes before anaesthetic induction
Drug: Dexmedetomidine
Either 2mcg/kg or 4mcg/kg of intranasal dexmedetomidine will be given to assess efficacy of preoperative sedation
Other Name: Precedex




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All children of American Society of Anesthesiologists (ASA) physical status classification I or II (healthy) between the ages of 6 months and 5 years undergoing surgery at Queen Mary Hospital

Exclusion Criteria:

  • Any patient receiving other sedative premedication, allergy to dexmedetomidine, organ dysfunction, cardiac arrhythmia and congenital heart disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459509


Contacts
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Contact: Sophie E Liu, MBBS 852 55086630 sophieliu@doctors.org.uk
Contact: Theresa Hui, MBBS 852 95368149 huiwct@ha.org.hk

Locations
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Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Sophie E Liu, MBBS    55086630    sophieliu@doctors.org.uk   
Contact: Theresa Hui, MBBS    95368149    huiwct@ha.org.hk   
Principal Investigator: Sophie E Liu, MBBS         
Sub-Investigator: Theresa Hui, MBBS         
Sub-Investigator: Grace Wong, MBBS         
Sub-Investigator: Vivian Yuen, MBBS         
Sub-Investigator: Michael G Irwin, MBChB         
Sub-Investigator: Silky Wong, MBBS         
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Sophie E Liu, MBBS Hong Kong University
Publications of Results:
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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02459509    
Other Study ID Numbers: UW 15-105
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016
Keywords provided by The University of Hong Kong:
Sedation
dexmedetomidine
pediatric
preoperative period
Additional relevant MeSH terms:
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Anxiety, Separation
Anxiety Disorders
Mental Disorders
Neurodevelopmental Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action