Intranasal Dexmedetomidine Sedation for Ophthalmic Examinations in Children (DEX-EYE)

Sun Yat-sen University

Status

Unknown

Conditions

Sniffs Drugs

Treatments

Drug: intranasal dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT02077712

CCPMOH2010-China4

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

2 months to 6 years old

Volunteers

No Healthy Volunteers

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