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

Sponsor:	The University of Texas Health Science Center, Houston
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00273754

Purpose

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).

Condition	Intervention	Phase
Sleep Apnea, Obstructive Tonsillectomy Adenoidectomy Postoperative Complications	Drug: Caffeine Drug: Placebo	Phase II

Study Type:	Interventional
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.

Resource links provided by NLM:

MedlinePlus related topics: Caffeine Sleep Apnea Tonsils and Adenoids

Drug Information available for: 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione

U.S. FDA Resources

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

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

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
Placebo Comparator: Placebo Saline	Drug: Placebo Children in group two will receive an amount of normal saline equal to Caffeine Other Name: Saline
Active Comparator: Caffeine Caffeine benzoate	Drug: Caffeine Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base. Other Name: Caffeine

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

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:

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, Children's Memorial Hermann Hospital
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

No publications provided

Responsible Party:	Samia Khalil, M.D., University of Texas Medical School, Houston
ClinicalTrials.gov Identifier:	NCT00273754 History of Changes
Other Study ID Numbers:	HSC-MS-03-108
Study First Received:	January 4, 2006
Results First Received:	June 5, 2009
Last Updated:	October 14, 2010
Health Authority:	United States: Institutional Review Board

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

Obstructive Sleep Apnea (OSA)
Tonsillectomy and Adenoidectomy (T&A)
Postoperative Complications
Recovery

Additional relevant MeSH terms:

Apnea
Postoperative Complications
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Caffeine
Caffeine, sodium benzoate drug combination

Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Antimutagenic Agents
Protective Agents
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on February 12, 2012