Does Caffeine Help Children With Obstructive Sleep Apnea Recover Faster From Anesthesia and With Less Complication After Tonsillectomy and Adenoidectomy? - Full Text View

Purpose

This is a research 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 up children faster and decrease post-anesthesia airway obstruction, as well as the safety and if the drug agrees with the child compared to a placebo, that is, an inactive or dummy agent.

Condition	Intervention	Phase
Sleep Apnea, Obstructive Tonsillectomy and Adenoidectomy Postoperative Complications	Drug: Caffeine (Drug)	Phase II

MedlinePlus related topics:

Anesthesia Caffeine Choking Sleep Apnea Tonsils and Adenoids

ChemIDplus related topics:

Sodium chloride Potassium benzoate 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione Caffeine citrate

U.S. FDA Resources

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

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

Complication in post operative care unit (PACU)eg:Upper airway obstruction ,Laryngospasm,Apnea,Desaturation [ Time Frame: 24 hours from anesthesia end ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Duration from anesthesia end until extubation time,Awakening time,PACU and DSU durations and hospital discharge time. [ Time Frame: 24 hours from anesthesia end ] [ Designated as safety issue: Yes ]

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
I: Active Comparator 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 postoperative complications, shorter stay in PACU, DSU and the hospital.	Drug: Caffeine (Drug) Children will be randomized into two groups:those in group one will receive caffeine benzoate 20 mg/kg i.v.,which is equal to 10mg/kg caffeine base,and those in group 2 will receive a similar volume of saline.

Detailed Description:

Patients with OSA are reported to have a higher rate of sever respiratory complications associated with upper airway obstruction during anesthesia and sedation or immediately after anesthesia. 8. Children with OSA (especially those under three years of age, those with sever OSA, cerebral palsy or craniofacial anomalies) are at increased risks for postoperative 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 postoperative complications, shorter stay in PACU, DSU and the hospital.

Eligibility

Ages Eligible for Study:	30 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children between 2.5-18 Years old
Diagnosed with Obstructive Sleep Apnea
Undergoing elective Tonsillectomy and Adenoidectomy

Exclusion Criteria:

Tonsillectomy or Adenoidectomy only
Age below 2.5 or above 18 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273754

Locations


United States, Texas
	University of Texas, Health Science Center at Houston
	Houston, Texas, United States, 77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators


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
First Received:	January 4, 2006
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00273754
Health Authority:	United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:

Obstructive Sleep Apnea (OSA)

Tonsillectomy and Adenoidectomy (T&A)

Postoperative Complications

Recovery

Study placed in the following topic categories:

Caffeine citrate

Sleep Apnea Syndromes

Apnea

Benzoates

Citric Acid

Sleep Apnea, Obstructive

Respiration Disorders

Sleep Disorders

Dyssomnias

Sleep Disorders, Intrinsic

Signs and Symptoms

Postoperative Complications

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Caffeine

Additional relevant MeSH terms:

Phosphodiesterase Inhibitors

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Central Nervous System Stimulants

Enzyme Inhibitors

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

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