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

This study has been completed.

Study NCT00273754 Information provided by The University of Texas Health Science Center, Houston

First Received on January 4, 2006. Last Updated on October 14, 2010 History of Changes

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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Reporting Groups

	Description
Placebo	Normal Saline
Caffeine	Caffeine benzoate

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. ]

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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. ]

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3. Secondary:

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

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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. ]

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5. Secondary:

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

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6. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

Limitations and Caveats

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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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

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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