CompletedPhase 4

Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation During Magnetic Resonance Imaging

China158 participantsStarted 2014-09

Plain-language summary

The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine is as effective as second dose of oral chloral hydrate for rescue sedation in infant age between 1 and 6 months who were not adequately sedated following initial dose of chloral hydrate.

Who can participate

Age range1 Month – 6 Months

SexALL

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Inclusion Criteria: * 160 children of ASA physical status I or II, aged between 1 and 6 months, failed chloral hydrate sedation during MRI scanning Exclusion Criteria: * known allergy or hypersensitive reaction to dexmedetomidine or CH, organ dysfunction, pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia or and congenital heart disease.

What they're measuring

successful rescue sedation rate

Timeframe: up to 1 hours after MRI scaning

Trial details

NCT IDNCT02239445

SponsorGuangzhou Women and Children's Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-05

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