Intranasal Dexmedetomidine Sedation for Ophthalmic Examinations in Children (DEX-EYE)

April 29, 2016 updated by: Haotian Lin, Sun Yat-sen University

A Randomised Comparison of Two Intranasal Dexmedetomidine Doses for Ophthalmic Examination Following Failed Chloral Hydrate Sedation in Children

2 ug/kg of intranasal dexmedetomidine could produce satisfactory sedation in more children for ophthalmic examinations than the sedative effect of 1ug/kg.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Dexmedetomidine is an a2-adrenergic receptor agonist that provides sedation without respiratory depression.Clinical trials have demonstrated that intranasal dexmedetomidine in a dose of 1ug/kg produces satisfactory sedation in between 53% and 57% of children at anaesthetic induction. There are also reports using higher doses of intranasal dexmedetomidine. The investigators compared the sedative effect of 1ug/kg intranasal dexmedetomidine with those of 2 ug/kg for ophthalmic examinations in children aged 2 months-10 years and hypothesised that the higher dose would produce satisfactory sedation in more children at the time of anaesthetic induction.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Need sedation for ophthalmic examinations
  • Children who had failed chloral hydrate sedation, i.e.there was no evidence of sedation 30 min following administration.
  • With informed consent from parents

Exclusion Criteria:

  • Children with gastroesophageal reflux
  • Children with nausea and vomiting
  • Children with apnea in the past three months
  • Children with recent pneumonia, exacerbation of asthma, bronchitis and upper respiratory tract infection
  • Children with severe arrhythmias, heart failure and cardiac structural abnormalities
  • Children with facial abnormalities, who is expected to be difficult with effective mask ventilation
  • Children with severe neurological disease
  • Children with moyamoya disease
  • Children who is allergy to For dexmedetomidine or chloral hydrate
  • Preterm children, weight <2 kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexmedetomidine 1 ug/kg
1 ug/kg of intranasal dexmedetomidine
Drug: intranasal dexmedetomidine
1 or 2 ug/kg of intranasal dexmedetomidine
Other Names:
  • Ai Bei Ning
Active Comparator: Dexmedetomidine 2 ug/kg
2 ug/kg of intranasal dexmedetomidine
Drug: intranasal dexmedetomidine
1 or 2 ug/kg of intranasal dexmedetomidine
Other Names:
  • Ai Bei Ning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numbers of participants with successful rescue sedation
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Numbers of participants with completement of ophthalmic examinations
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Ministry of Health, China

Investigators

  • Study Chair: Yizhi Liu, Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Principal Investigator: Xiaoliang Gan, Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Study Director: Weirong Chen, Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

March 2, 2014

First Posted (Estimate)

March 4, 2014

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

April 29, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCPMOH2010-China4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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