The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).
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| Tracking Information | |||||
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| First Received Date ICMJE | January 4, 2006 | ||||
| Last Updated Date | October 14, 2010 | ||||
| Start Date ICMJE | September 2003 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: Yes ] The number of children having adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the Operating Room and in the PACU was recorded. |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00273754 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA). | ||||
| Official Title ICMJE | A Pilot Study to Evaluate if Caffeine Helps Children With Obstructive Sleep Apnea Recover Faster From Anesthesia, and With Less Complications After General Anesthesia for Tonsillectomy and Adenoidectomy. | ||||
| Brief Summary | This is a research study using caffeine in children who have an obstructive sleep apnea (OSA). OSA means children who stop breathing during their sleep due to obstruction in their airway. The purpose of this study is to determine whether caffeine when given in the vein, will wake children up faster and decrease post-anesthesia airway obstruction, as well as the safety and if the drug agrees with the child compared to a placebo (an inactive or dummy agent). |
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| Detailed Description | Patients with OSA are reported to have a higher rate of severe respiratory complications associated with upper airway obstruction during anesthesia and sedation or immediately after anesthesia. Children with OSA (especially those under three years of age, those with severe OSA, cerebral palsy or craniofacial anomalies) are at increased risks for post-operative complications, and require careful monitoring post-operatively. Although the etiology of obstructive sleep apnea is mainly obstruction due to anatomical and neuromuscular abnormalities, we believe that a central element may contribute to OSA. The aim of this study is to evaluate whether administration of caffeine to children with OSA, scheduled for elective T & A under general anesthesia contributes to a faster recovery, less post-operative complications, and a shorter stay in the PACU, DSU and the hospital. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 74 | ||||
| Completion Date | May 2008 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Months to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00273754 | ||||
| Other Study ID Numbers ICMJE | HSC-MS-03-108 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Samia Khalil, M.D., University of Texas Medical School, Houston | ||||
| Study Sponsor ICMJE | The University of Texas Health Science Center, Houston | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The University of Texas Health Science Center, Houston | ||||
| Verification Date | October 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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