NCT02077712

Brief Summary

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

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

February 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 3, 2016

Status Verified

April 1, 2016

Enrollment Period

3.3 years

First QC Date

February 27, 2014

Last Update Submit

April 29, 2016

Conditions

Sniffs Drugs

Outcome Measures

Primary Outcomes (1)

  • Numbers of participants with successful rescue sedation

    1 day

Secondary Outcomes (1)

  • Numbers of participants with completement of ophthalmic examinations

    1 day

Study Arms (2)

Dexmedetomidine 1 ug/kg

ACTIVE COMPARATOR

1 ug/kg of intranasal dexmedetomidine

Drug: intranasal dexmedetomidine

Dexmedetomidine 2 ug/kg

ACTIVE COMPARATOR

2 ug/kg of intranasal dexmedetomidine

Drug: intranasal dexmedetomidine

Interventions

intranasal dexmedetomidineDRUG

1 or 2 ug/kg of intranasal dexmedetomidine

Also known as: Ai Bei Ning
Dexmedetomidine 1 ug/kgDexmedetomidine 2 ug/kg

Eligibility Criteria

Age2 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (5)

  • Ambi US, Joshi C, Ganeshnavar A, Adarsh E. Intranasal dexmedetomidine for paediatric sedation for diagnostic magnetic resonance imaging studies. Indian J Anaesth. 2012 Nov;56(6):587-8. doi: 10.4103/0019-5049.104588. No abstract available.

    PMID: 23325950BACKGROUND

  • Ray T, Tobias JD. Dexmedetomidine for sedation during electroencephalographic analysis in children with autism, pervasive developmental disorders, and seizure disorders. J Clin Anesth. 2008 Aug;20(5):364-368. doi: 10.1016/j.jclinane.2008.03.004.

    PMID: 18761245BACKGROUND

  • Li BL, Yuen VM, Song XR, Ye J, Ni J, Huang JX, Irwin MG. Intranasal dexmedetomidine following failed chloral hydrate sedation in children. Anaesthesia. 2014 Mar;69(3):240-4. doi: 10.1111/anae.12533. Epub 2014 Jan 21.

    PMID: 24447296RESULT

  • Fong CY, Lim WK, Li L, Lai NM. Chloral hydrate as a sedating agent for neurodiagnostic procedures in children. Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3.

    PMID: 34397100DERIVED

  • Gan X, Lin H, Chen J, Lin Z, Lin Y, Chen W. Rescue Sedation With Intranasal Dexmedetomidine for Pediatric Ophthalmic Examination After Chloral Hydrate Failure: A Randomized, Controlled Trial. Clin Ther. 2016 Jun;38(6):1522-1529. doi: 10.1016/j.clinthera.2016.04.036. Epub 2016 May 24.

    PMID: 27229908DERIVED

Related Links

Study Officials

  • Haotian Lin, Ph.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Xiaoliang Gan, Ph.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Weirong Chen

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY DIRECTOR

  • Yizhi Liu, Ph.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Haotian Lin

CONTACT

862087330493gddlht@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmologist

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 4, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

May 3, 2016

Record last verified: 2016-04

Locations

CN(1)