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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00273754
First Posted: January 9, 2006
Last Update Posted: June 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Samia Khalil, The University of Texas Health Science Center, Houston
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Samia Khalil, 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. ]
    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. ]
    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. ]
    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. ]
    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. ]
  • Hospital Discharge Time [ Time Frame: 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.


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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Samia Khalil, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00273754     History of Changes
Other Study ID Numbers: HSC-MS-03-108
First Submitted: January 4, 2006
First Posted: January 9, 2006
Results First Submitted: June 5, 2009
Results First Posted: November 10, 2010
Last Update Posted: June 16, 2016
Last Verified: May 2016

Keywords provided by Samia Khalil, 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
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Postoperative Complications
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathologic Processes
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents