Clinical trial NCT00273754: The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Apnea, Obstructive
Tonsillectomy
Adenoidectomy
Postoperative Complications
Keywords: Obstructive Sleep Apnea (OSA)
Tonsillectomy and Adenoidectomy (T&A)
Postoperative Complications
Recovery
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2006-01-09
Enrollment: 74
Sex: ALL
Minimum age (years): 30
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo.
timeFrame: Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.
Secondary outcomes:
measure: Occurence of Post Extubatory Respiratory Adverse Events.
timeFrame: Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.
measure: Extubation Time.
timeFrame: Duration from anesthesia end until extubation time.
measure: Awakening Time
timeFrame: Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score.
measure: Post Anesthesia Care Unit (PACU) Duration
timeFrame: Time spent in PACU following surgical procedure prior to discharge home or hospital admission.
measure: Hospital Discharge Time
timeFrame: Total time from end anesthesia to discharge home
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas, Health Science Center at Houston, Children's Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Samia N. Khalil, MD
role: PRINCIPAL_INVESTIGATOR
References: