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The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA). (OSA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samia Khalil, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00273754
First received: January 4, 2006
Last updated: May 12, 2016
Last verified: May 2016
Results First Received: June 5, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Sleep Apnea, Obstructive
Tonsillectomy
Adenoidectomy
Postoperative Complications
Interventions: Drug: Caffeine
Drug: 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
Placebo Normal Saline
Caffeine Caffeine benzoate

Participant Flow:   Overall Study
    Placebo   Caffeine
STARTED   36   36 
COMPLETED   36   36 
NOT COMPLETED   0   0 



  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
Placebo Normal Saline
Caffeine Caffeine benzoate
Total Total of all reporting groups

Baseline Measures
   Placebo   Caffeine   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   36   72 
Age 
[Units: Participants]
     
<=18 years   36   36   72 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 5.3  (2.9)   5.3  (2.2)   5.3  (2.5) 
Gender 
[Units: Participants]
     
Female   17   19   36 
Male   19   17   36 
Region of Enrollment 
[Units: Participants]
     
United States   36   36   72 


  Outcome Measures
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1.  Primary:   Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo.   [ Time Frame: Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room. ]

2.  Secondary:   Occurence of Post Extubatory Respiratory Adverse Events.   [ Time Frame: Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room. ]

3.  Secondary:   Extubation Time.   [ Time Frame: Duration from anesthesia end until extubation time. ]

4.  Secondary:   Awakening Time   [ Time Frame: Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score. ]

5.  Secondary:   Post Anesthesia Care Unit (PACU) Duration   [ Time Frame: Time spent in PACU following surgical procedure prior to discharge home or hospital admission. ]

6.  Secondary:   Hospital Discharge Time   [ Time Frame: Total time from end anesthesia to discharge home ]


  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
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  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: Samia Khalil, M.D./ Professor
Organization: University of Texas Medical School/ Houston
phone: 713-500-6242
e-mail: Samia.N.Khalil@uth.tmc.edu



Responsible Party: Samia Khalil, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00273754     History of Changes
Other Study ID Numbers: HSC-MS-03-108
Study First Received: January 4, 2006
Results First Received: June 5, 2009
Last Updated: May 12, 2016