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Comparison of sedation effects between oral Chloral Hydrate and intranasal Dexmedetomidine on pediatric non-invasive ophthalmic examinations: A Randomized Controlled Trial

Comparison of sedation effects between oral Chloral Hydrate and intranasal Dexmedetomidine on pediatric non-invasive ophthalmic examinations: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-15006975
Enrollment
Unknown
Registered
2015-08-26
Start date
2015-09-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric sedation on ophthalmic examinations

Interventions

Chloral hydrate:oral 80 mg/kg of Chloral hydrate
Dexmedetomidine:Intranasal 2 µg/kg of dexmedetomidine

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: (1) Need sedation for ophthalmic examinations; (2) With informed consent from the parents.

Exclusion criteria

Exclusion criteria: (1) Children with gastroesophageal reflux; (2) Children with nausea and vomiting; (3) Children with apnea in the past three months; (4) Children with recent pneumonia, exacerbation of asthma, bronchitis and upper respiratory tract infection; (5) Children with severe arrhythmias, heart failure and cardiac structural abnormalities; (6) Children with facial abnormalities, who is expected to be difficult with effective mask ventilation; (7) Children with severe neurological disease; (8) Children with moyamoya disease; (9) Children who is allergy for dexmedetomidine or chloral hydrate; (10) Children who were enrolled in the present study previously; (11) Preterm children, weight <2 kg, or age <2 month.

Design outcomes

Primary

MeasureTime frame
Successful sedation;Nausea vomitting;Respiratory depression;appetite;

Secondary

MeasureTime frame
Examination time;Awake time;Discharge time;

Countries

China

Contacts

Public ContactXiaoliang Gan
ganxl@mail.sysu.edu.cn+86 020-87331548

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026