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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Administration Related Reaction Failed Moderate Sedation During Procedure Chloral Hydrate Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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chloral hydrate group

chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)

Group Type ACTIVE_COMPARATOR

chloral hydrate Group

Intervention Type DRUG

chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)

low dose dexmedetomidine Group

Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup

Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position.

Group Type EXPERIMENTAL

low dose dexmedetomidine group

Intervention Type DRUG

Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup

high dose dexmedetomidine group

Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup

Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position.

Group Type EXPERIMENTAL

high dose dexmedetomidine group

Intervention Type DRUG

Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup

Interventions

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chloral hydrate Group

chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)

Intervention Type DRUG

low dose dexmedetomidine group

Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup

Intervention Type DRUG

high dose dexmedetomidine group

Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup

Intervention Type DRUG

Other Intervention Names

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AiBeiNing AiBeiNing

Eligibility Criteria

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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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No