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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 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).
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Apnea, Obstructive Tonsillectomy Adenoidectomy Postoperative Complications |
Drug: Caffeine (Drug) |
Phase II |
| 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 |
|---|---|
|
Placebo: Placebo Comparator
Saline
|
Drug: Caffeine (Drug)
Children will be randomized into one of two groups: those in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base. Those in group two will receive a similar volume of saline. |
|
Caffeine: Active Comparator
Caffeine benzoate
|
Drug: Caffeine (Drug)
Children will be randomized into one of two groups: those in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base. Those in group two will receive a similar volume of saline. |
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.
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 | |
| 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 |
| Study First Received: | January 4, 2006 |
| Last Updated: | January 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00273754 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Obstructive Sleep Apnea (OSA) Tonsillectomy and Adenoidectomy (T&A) Postoperative Complications Recovery |
|
Caffeine citrate Sleep Apnea Syndromes Apnea Benzoates Citric Acid Sleep Apnea, Obstructive Respiration Disorders Central Nervous System Depressants Sleep Disorders Dyssomnias |
Anesthetics Central Nervous System Stimulants Sleep Disorders, Intrinsic Signs and Symptoms Phosphodiesterase Inhibitors Postoperative Complications Respiratory Tract Diseases Citrate Signs and Symptoms, Respiratory Caffeine |
|
Molecular Mechanisms of Pharmacological Action Sleep Apnea, Obstructive Physiological Effects of Drugs Sleep Disorders Anesthetics Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Respiratory Tract Diseases Therapeutic Uses Signs and Symptoms, Respiratory Caffeine Caffeine citrate |
Sleep Apnea Syndromes Apnea Nervous System Diseases Respiration Disorders Dyssomnias Central Nervous System Depressants Enzyme Inhibitors Central Nervous System Stimulants Pharmacologic Actions Phosphodiesterase Inhibitors Postoperative Complications Central Nervous System Agents |
