A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Jason Reynolds, Baylor College of Medicine

ClinicalTrials.gov Identifier:

NCT01255904

First received: November 18, 2010

Last updated: April 12, 2016

Last verified: April 2016

History of Changes

Results First Received: January 25, 2016

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver); Primary Purpose: Treatment
Condition:	Sedation
Interventions:	Drug: Chloral Hydrate Drug: Dexmedetomidine Other: Oral placebo Other: Intranasal placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Oral Placebo and Intransal Dexmedetomidine	Oral placebo followed by Intranasal dexmedetomidine 3 mcg/kg (max dose 100 mcg).
Oral Chloral Hydrate and Intranasal Placebo	50 mg/kg oral chloral hydrate followed by intranasal placebo.

Participant Flow: Overall Study

	Oral Placebo and Intransal Dexmedetomidine	Oral Chloral Hydrate and Intranasal Placebo
STARTED	45	45
COMPLETED	44	41
NOT COMPLETED	1	4
Physician Decision	1	4

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Oral Placebo and Intransal Dexmedetomidine	No text entered.
Oral Chloral Hydrate and Intranasal Placebo	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Oral Placebo and Intransal Dexmedetomidine	Oral Chloral Hydrate and Intranasal Placebo	Total
Number of Participants [units: participants]	44	41	85
Age [units: months] Mean (Standard Deviation)	23.33 (12.63)	25.55 (11.21)	24.40 (11.95)
Gender [units: participants]
Female	21	14	35
Male	23	27	50
Region of Enrollment [units: participants]
United States	44	41	85

Outcome Measures

1. Primary:

Time to Complete Study [ Time Frame: 60-180 minutes ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Jason Reynolds
Organization: Baylor College of Medicine
phone: (210) 704-2680
e-mail: jmreynol@bcm.edu

Responsible Party:	Jason Reynolds, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT01255904 History of Changes
Other Study ID Numbers:	H-27453
Study First Received:	November 18, 2010
Results First Received:	January 25, 2016
Last Updated:	April 12, 2016
Health Authority:	United States: Food and Drug Administration

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