Intranasal Dexmedetomidine Sedation for Ophthalmic Examinations in Children

Not Applicable

• Conditions: Sniffs Drugs
• Interventions: Drug: intranasal dexmedetomidine

• Registration Number: NCT02077712
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-03-02
• Study First Posted: 2014-03-04
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-29
• Last Update Posted: 2016-05-03
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine 1 ug/kg	intranasal dexmedetomidine	1 ug/kg of intranasal dexmedetomidine
Dexmedetomidine 2 ug/kg	intranasal dexmedetomidine	2 ug/kg of intranasal dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Numbers of participants with successful rescue sedation	1 day

Secondary Outcome Measures

Name	Time	Method
Numbers of participants with completement of ophthalmic examinations	1 day

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China