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
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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.
No text entered.

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 ]


  Serious Adverse Events


  Other Adverse Events


  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