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| Sponsored by: |
The University of Texas Health Science Center, Houston |
| Information provided by: | The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT00273754 |
Purpose
This is a research 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 up children faster and decrease post-anesthesia airway obstruction, as well as the safety and if the drug agrees with the child compared to a placebo, that is, an inactive or dummy agent.
| Condition | Intervention | Phase |
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Sleep Apnea, Obstructive Tonsillectomy and Adenoidectomy Postoperative Complications |
Drug: Caffeine (Drug) |
Phase II |
| MedlinePlus related topics: | Anesthesia Caffeine Choking Sleep Apnea Tonsils and Adenoids |
| ChemIDplus related topics: | Sodium chloride Potassium benzoate 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione Caffeine citrate |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Enrollment: | 74 |
| Study Start Date: | September 2003 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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I: Active Comparator
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 postoperative complications, shorter stay in PACU, DSU and the hospital.
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Drug: Caffeine (Drug)
Children will be randomized into two groups:those in group one will receive caffeine benzoate 20 mg/kg i.v.,which is equal to 10mg/kg caffeine base,and those in group 2 will receive a similar volume of saline.
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Patients with OSA are reported to have a higher rate of sever respiratory complications associated with upper airway obstruction during anesthesia and sedation or immediately after anesthesia. 8. Children with OSA (especially those under three years of age, those with sever OSA, cerebral palsy or craniofacial anomalies) are at increased risks for postoperative 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 postoperative complications, shorter stay in PACU, DSU and the hospital.
Eligibility
| Ages Eligible for Study: | 30 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |||||
| University of Texas, Health Science Center at Houston | |||||
| Houston, Texas, United States, 77030 | |||||
| The University of Texas Health Science Center, Houston |
| Principal Investigator: | Samia N Khalil, MD | The University of Texas Health Science Center, Houston |
More Information
| Responsible Party: | University of Texas Medical School, Houston ( Samia Khalil, M.D. ) |
| Study ID Numbers: | HSC-MS-03-108 |
| First Received: | January 4, 2006 |
| Last Updated: | July 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00273754 |
| Health Authority: | United States: Food and Drug Administration |
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