NCT02459509

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 18, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

May 20, 2015

Last Update Submit

April 15, 2016

Conditions

Anxiety, Separation

Keywords

Sedationdexmedetomidinepediatricpreoperative period

Outcome Measures

Primary Outcomes (1)

  • Satisfactory sedation

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

    From 30 minutes post drug administration to induction of anaesthesia (average 30 minutes)

Secondary Outcomes (4)

  • Time to satisfactory sedation

    From time of drug administration to when Observer's Assessment of Alertness/ Sedation Score is 2 or less (from 0 minutes to 30 minutes)

  • Blood pressure

    From drug administration to end of anaesthesia (on average 1 to 3 hours)

  • Heart rate

    From drug administration to end of anaesthesia (on average 1 to 3 hours)

  • Oxygen saturations

    From drug administration to end of anaesthesia (on average 1 to 3 hours)

Study Arms (2)

Dexmedetomidine 2 mcg/kg

ACTIVE COMPARATOR

2 mcg/kg dexmedetomidine given intranasally once at least 30 minutes before anaesthetic induction

Drug: Dexmedetomidine

Dexmedetomidine 4 mcg/kg

ACTIVE COMPARATOR

4 mcg/kg dexmedetomidine given intranasally once at least 30 minutes before anaesthetic induction

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Either 2mcg/kg or 4mcg/kg of intranasal dexmedetomidine will be given to assess efficacy of preoperative sedation

Also known as: Precedex
Dexmedetomidine 2 mcg/kgDexmedetomidine 4 mcg/kg

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (5)

  • Pestieau SR, Quezado ZM, Johnson YJ, Anderson JL, Cheng YI, McCarter RJ, Choi S, Finkel JC. High-dose dexmedetomidine increases the opioid-free interval and decreases opioid requirement after tonsillectomy in children. Can J Anaesth. 2011 Jun;58(6):540-50. doi: 10.1007/s12630-011-9493-7. Epub 2011 Apr 2.

    PMID: 21461792RESULT

  • Mason KP, Zurakowski D, Zgleszewski SE, Robson CD, Carrier M, Hickey PR, Dinardo JA. High dose dexmedetomidine as the sole sedative for pediatric MRI. Paediatr Anaesth. 2008 May;18(5):403-11. doi: 10.1111/j.1460-9592.2008.02468.x. Epub 2008 Mar 18.

    PMID: 18363626RESULT

  • Mason KP, Lubisch NB, Robinson F, Roskos R. Intramuscular dexmedetomidine sedation for pediatric MRI and CT. AJR Am J Roentgenol. 2011 Sep;197(3):720-5. doi: 10.2214/AJR.10.6134.

    PMID: 21862817RESULT

  • Yuen VM, Irwin MG, Hui TW, Yuen MK, Lee LH. A double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine. Anesth Analg. 2007 Aug;105(2):374-80. doi: 10.1213/01.ane.0000269488.06546.7c.

    PMID: 17646493RESULT

  • Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz Hasan M, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012 Nov;67(11):1210-6. doi: 10.1111/j.1365-2044.2012.07309.x. Epub 2012 Sep 5.

    PMID: 22950484RESULT

MeSH Terms

Conditions

Anxiety, Separation

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersNeurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sophie E Liu, MBBS

    Hong Kong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie E Liu, MBBS

CONTACT

852 55086630sophieliu@doctors.org.uk

Theresa Hui, MBBS

CONTACT

852 95368149huiwct@ha.org.hk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2015

First Posted

June 2, 2015

Study Start

June 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

April 18, 2016

Record last verified: 2016-04

Locations

HK(1)