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

NCT02239445 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2015-05-12

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

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)

DRUG

low dose dexmedetomidine group

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

DRUG

high dose dexmedetomidine group

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

Sponsors & Collaborators

  • Guangzhou Women and Children's Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02239445 on ClinicalTrials.gov