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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 May 2015
• Main ID: NCT02239445
• Date of registration: 04/09/2014
• Prospective Registration: No
• Primary sponsor: Guangzhou Women and Children's Medical Center
• Public title: Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation During Magnetic Resonance Imaging
• Date of first enrolment: September 2014
• Target sample size: 158
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02239445
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator)
• Phase: Phase 4

Countries of recruitment

China

Key inclusion & exclusion criteria

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.



Age minimum: 1 Month
Age maximum: 6 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Administration Related Reaction

Chloral Hydrate Adverse Reaction

Failed Moderate Sedation During Procedure

Intervention(s)

Drug: chloral hydrate Group

Drug: low dose dexmedetomidine group

Drug: high dose dexmedetomidine group

Primary Outcome(s)

successful rescue sedation rate [Time Frame: up to 1 hours after MRI scaning]

Secondary Outcome(s)

Wake -up time [Time Frame: up to 4 hours after rescue drug administration]

sedation induction time [Time Frame: up to 30 min after rescue drug administration]

Secondary ID(s)

WZhang

Source(s) of Monetary Support

Please refer to primary and secondary sponsors