The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).
Sleep Apnea, Obstructive
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|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.|
- 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.
- 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. ] [ Designated as safety issue: Yes ]The overall occurance of 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 OR and in the PACU was noted.
- Extubation Time. [ Time Frame: Duration from anesthesia end until extubation time. ] [ Designated as safety issue: Yes ]Time from end of anesthesia until extubation.
- Awakening Time [ Time Frame: Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score. ] [ Designated as safety issue: Yes ]A child with a Steward Recovery Scale score of 6 is defined as awake, coughing/crying, and has purposeful movements.
- Post Anesthesia Care Unit (PACU) Duration [ Time Frame: Time spent in PACU following surgical procedure prior to discharge home or hospital admission. ] [ Designated as safety issue: Yes ]
- Hospital Discharge Time [ Time Frame: Total time from end anesthesia to discharge home ] [ Designated as safety issue: Yes ]Children were discharged from the hospital when they reached the hospital discharge criteria: they were awake, had stable vital signs, were breathing adequately, had O2 saturation >95% while breathing room air, were able to swallow fluids, had no or minimal pain, and were able to ambulate without excessive nausea, vomiting, or dizziness.
|Study Start Date:||September 2003|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Children in group two will receive an amount of normal saline equal to Caffeine
Other Name: Saline
Active Comparator: Caffeine
Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273754
|United States, Texas|
|University of Texas, Health Science Center at Houston, Children's Memorial Hermann Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Samia N. Khalil, MD||The University of Texas Health Science Center, Houston|