Clinical trial NCT02077712: Intranasal Dexmedetomidine Sedation for Ophthalmic Examinations in Children
Official title: A Randomised Comparison of Two Intranasal Dexmedetomidine Doses for Ophthalmic Examination Following Failed Chloral Hydrate Sedation in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sniffs Drugs
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, China
First posted: 2014-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numbers of participants with successful rescue sedation
timeFrame: 1 day
Secondary outcomes:
measure: Numbers of participants with completement of ophthalmic examinations
timeFrame: 1 day
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xiaoliang Gan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Weirong Chen
role: STUDY_DIRECTOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, Ph.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.