Intranasal Dexmedetomidine Sedation for Ophthalmic Examinations in Children
NCT ID: NCT02077712
Last Updated: 2016-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2014-02-28
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Dexmedetomidine 1 ug/kg
1 ug/kg of intranasal dexmedetomidine
intranasal dexmedetomidine
1 or 2 ug/kg of intranasal dexmedetomidine
Dexmedetomidine 2 ug/kg
2 ug/kg of intranasal dexmedetomidine
intranasal dexmedetomidine
1 or 2 ug/kg of intranasal dexmedetomidine
Interventions
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intranasal dexmedetomidine
1 or 2 ug/kg of intranasal dexmedetomidine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
2 Months
6 Years
ALL
No
Sponsors
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Ministry of Health, China
OTHER_GOV
Sun Yat-sen University
OTHER
Responsible Party
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Haotian Lin
Ophthalmologist
Principal Investigators
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Haotian Lin, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Xiaoliang Gan, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Weirong Chen
Role: STUDY_DIRECTOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, Ph.D.
Role: STUDY_CHAIR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Locations
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Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Related Links
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Homepage of Zhongshan Ophthalmic Center
Other Identifiers
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CCPMOH2010-China4
Identifier Type: -
Identifier Source: org_study_id
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