Intranasal Dexmedetomidine Sedation for Ophthalmic Examinations in Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sniffs Drugs

Intervention / Treatment
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* Drug: intranasal dexmedetomidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine 1 ug/kg<br>1 ug/kg of intranasal dexmedetomidine | Drug: intranasal dexmedetomidine<br>* 1 or 2 ug/kg of intranasal dexmedetomidine<br>* Other names: Ai Bei Ning;|
| Active Comparator: Dexmedetomidine 2 ug/kg<br>2 ug/kg of intranasal dexmedetomidine | Drug: intranasal dexmedetomidine<br>* 1 or 2 ug/kg of intranasal dexmedetomidine<br>* Other names: Ai Bei Ning;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of participants with successful rescue sedation |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of participants with completement of ophthalmic examinations |  | 1 day |