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

Phase 2

Completed

Conditions: Tonsillectomy
Postoperative Complications
Adenoidectomy
Sleep Apnea, Obstructive

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).

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Saline
Caffeine	Caffeine	Caffeine benzoate

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Extubation Time.	Duration from anesthesia end until extubation time.	Time from end of anesthesia until extubation.
Occurence of Post Extubatory Respiratory Adverse Events.	Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.	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.
Awakening Time	Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score.	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 spent in PACU following surgical procedure prior to discharge home or hospital admission.
Hospital Discharge Time	Total time from end anesthesia to discharge home	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.

Locations (1): University of Texas, Health Science Center at Houston, Children's Memorial Hermann Hospital
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Houston, Texas, United States