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The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Oral Chloral and intranasal placebo |
|
| Arm 2 | Experimental | oral placebo and intranasal dexmedetomidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloral Hydrate | Drug | Oral chloral hydrate 50 mg/kg |
| |
| Dexmedetomidine |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Complete Study | Time from medication administration to study completion. | 60-180 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Childrens Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34397100 | Derived | Fong CY, Lim WK, Li L, Lai NM. Chloral hydrate as a sedating agent for neurodiagnostic procedures in children. Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Placebo and Intransal Dexmedetomidine | Oral placebo followed by Intranasal dexmedetomidine 3 mcg/kg (max dose 100 mcg). |
| FG001 | Oral Chloral Hydrate and Intranasal Placebo | 50 mg/kg oral chloral hydrate followed by intranasal placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Placebo and Intransal Dexmedetomidine | |
| BG001 | Oral Chloral Hydrate and Intranasal Placebo | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Complete Study | Time from medication administration to study completion. | Posted | Median | 95% Confidence Interval | Minutes | 60-180 minutes |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Placebo and Intransal Dexmedetomidine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild hypoxia < 94% and > 90% | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
This study was not designed to detect small differences in rare adverse and the overall safety of either medication cannot be assessed based on these results alone.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Reynolds | Baylor College of Medicine | (210) 704-2680 | jmreynol@bcm.edu |
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| ID | Term |
|---|---|
| D002697 | Chloral Hydrate |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Drug |
Intranasal dexmedetomidine 3 mcg/kg |
|
| Oral placebo | Other | Oral saline administered |
|
| Intranasal placebo | Other | Intranasal saline administered |
|
Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 44 |
| 2 |
| 44 |
| EG001 | Oral Chloral Hydrate and Intranasal Placebo | 0 | 41 | 0 | 41 |
| partial airway obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |