Trials / Completed
CompletedNCT02239445
Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation During Magnetic Resonance Imaging
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 158 (actual)
- Sponsor
- Guangzhou Women and Children's Medical Center · Academic / Other
- Sex
- All
- Age
- 1 Month – 6 Months
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2015-05-01
- Completion
- 2015-05-01
- First posted
- 2014-09-12
- Last updated
- 2015-05-12
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02239445. Inclusion in this directory is not an endorsement.