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

Guangzhou Women and Children's Medical Center158 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

158

Conditions

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

Interventions

chloral hydrate GroupDRUG

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 groupDRUG

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

high dose dexmedetomidine groupDRUG

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

Eligibility

Sex: ALLMin age: 1 MonthMax age: 6 Months

Medical Language ↔ Plain English

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.

Locations (2)

Department of Anesthesiology of Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

successful rescue sedation rate

Sedation status was evaluated by a attending anesthesiologists every 5-10 min with a 6-point sedation scale, which was modified from the Observer Assessment of Alertness and Sedation Scale (MOAA/S; Table 1). successful sedation was defined as an MOAA/S of between 0 and 3

Time frame: up to 1 hours after MRI scaning

Secondary Outcomes

sedation induction time

Successful sedation was defined as an MOAA/S of between 0 and 2, and sedation induction time was defined as the time from rescue drug administration to the onset of satisfactory sedation 0 Does not respond to a noxious stimulus 1. Does not respond to mild prodding or shaking 2. Responds only after mild prodding or shaking 3. Responds only after name is called loudly orrepeatedly 4. Lethargic response to name spoken in normal tone 5. Appears asleep, but responds readily to namespoken in normal tone 6. Appears alert and awake, responds readily to namespoken in normal tone

Time frame: up to 30 min after rescue drug administration

Wake -up time

Children were classified as awake if the MOAA/S was between 4 and 6. Wake -up time was defined as the time from successful sedation until the time that the child awoke

Time frame: up to 4 hours after rescue drug administration

Data from ClinicalTrials.gov

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