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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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.

Conditions
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Sleep Apnea, Obstructive, Tonsillectomy, Adenoidectomy, Postoperative Complications

Intervention / Treatment
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* Drug: Caffeine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 2.5-18 years old Diagnosed with obstructive sleep apnea Undergoing elective tonsillectomy and adenoidectomy Exclusion Criteria: Age below 2.5 or above 18 years

Ages Eligible for Study
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Minimum Age: 30 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Saline | Drug: Placebo<br>* Children in group two will receive an amount of normal saline equal to Caffeine<br>* Other names: Saline;|
| Active Comparator: Caffeine<br>Caffeine benzoate | Drug: Caffeine<br>* Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo. | 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. | Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of Post Extubatory Respiratory Adverse Events. | 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. | Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room. | 
| Extubation Time. | Time from end of anesthesia until extubation. | Duration from anesthesia end until extubation time. | 
| Awakening Time | A child with a Steward Recovery Scale score of 6 is defined as awake, coughing/crying, and has purposeful movements. | Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score. | 
| Post Anesthesia Care Unit (PACU) Duration |  | Time spent in PACU following surgical procedure prior to discharge home or hospital admission. | 
| Hospital Discharge Time | 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. | Total time from end anesthesia to discharge home | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea (OSA), Tonsillectomy and Adenoidectomy (T&A), Postoperative Complications, Recovery