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

This study has been completed.
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00273754
First received: January 4, 2006
Last updated: October 14, 2010
Last verified: October 2010
Results First Received: June 5, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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  
Number of Participants  
[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


No publications provided


Responsible Party: Samia Khalil, M.D., University of Texas Medical School, 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: October 14, 2010
Health Authority: United States: Institutional Review Board