Caffeine in Children With Obstructive Sleep Apnea, Dose Response Study

This study has been terminated.
(The study medication in not available in the market)
Sponsor:
Collaborator:
Memorial Hermann Hospital
Information provided by (Responsible Party):
Samia Khalil, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01349205
First received: May 3, 2011
Last updated: December 11, 2015
Last verified: December 2015
  Purpose
The aim of this study is to evaluate whether a smaller dose of caffeine sodium benzoate 10 mg/kg IV is as effective as 20 mg/kg IV in decreasing the number of children who develop post extubation adverse upper airway respiratory events compared to placebo.

Condition Intervention
Obstructive Sleep Apnea
Enlargement of Tonsil or Adenoid
Drug: Caffeine and sodium Benzoate 10 mg/kg IV
Drug: Caffeine and Sodium Benzoate 20 mg/kg IV
Drug: 0.9 NS Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Caffeine in Children With Obstructive Sleep Apnea, Dose Response Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Effects of Caffeine [ Time Frame: Immediately after drug administration upto 24 hours ] [ Designated as safety issue: Yes ]
    The primary outcome of the study is the number of children who develop adverse postextubation respiratory events, including: 1) airway obstruction, requiring jaw-chin thrust maneuver, or placement of an LMA or endotracheal tube, 2) laryngospasm, requiring continuous positive airway pressure or intervention with a muscle relaxant, 3) apnea, 4) desaturation(defined as a decrease in oxygen saturation <95% while breathing oxygen via mask which is our hospital and PACU nurses standard of care), 5) hypoventilation/ hypercapnia )


Secondary Outcome Measures:
  • Caffeine Drug Effects [ Time Frame: Immediately after drug administration to 24 hours ] [ Designated as safety issue: Yes ]
    A secondary outcome of the study will be the incidence of adverse post-extubation respiratory events.


Enrollment: 42
Study Start Date: March 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caffeine and Sodium Benzoate 10 mg/kg IV
Group 1 of randomized study.
Drug: Caffeine and sodium Benzoate 10 mg/kg IV
IV, 10mg/kg, IVP, 1 time
Experimental: Caffeine and Sodium Benzoate 20 mg/kg IV
Group 2 of randomized study
Drug: Caffeine and Sodium Benzoate 20 mg/kg IV
IV, 20 mg/kg, IVP, 1 time
Placebo Comparator: 0.9 NS Saline
Control group of randomized study.
Drug: 0.9 NS Saline
IV, 0-10 ml, IVP, 1 time

Detailed Description:
Institutional approval and written informed consent from parents or guardians of healthy children, with obstructive sleep apnea (OSA) and/or with increased end-tidal C02 (sleep related hypoventilation, obstructive hypoventilation or sustained alveolar hypoventilation), confirmed with sleep study, scheduled for elective outpatient or inpatient adeno-tonsillectomy at our hospital, will be obtained. The study will be prospective, randomized, double blinded and placebo controlled. A computer generated randomization list will be used, and the study will be registered with clinical.trials.gov. Written child assent will be obtained from children 7 years and older. Copies of a flyer and an explanation of the study will be provided at the office of all the pediatric ENT surgeons who practice at the Memorial Hermann Hospital OR. The investigators will communicate with the nurses at the surgeons' office and ask them to give the flyer with an explanation of the study to the parents and children on the day they schedule the surgery. The flyer with an explanation of study will be sent to IRB for review and approval. A research assistant will invite parents or guardians in the DSU unit, anesthesia clinic or on the floor to allow their children to be part of the study. Children with OSA and/or increased end tidal C02 (sleep related hypoventilation, obstructive hypoventilation or sustained alveolar hypoventilation), 2-12 years of age, and both genders will be eligible to be part of the study. OSA and its severity will be diagnosed by a preoperative polysomnography. Children with compromised cardiovascular, pulmonary or renal function, those with congenital syndromes, sickle cell disease, history of seizures and those receiving theophylline will be excluded.
  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children with OSA and/or increased end tidal C02 (sleep related hypoventilation, obstructive hypoventilation or sustained alveolar hypoventilation), 2-12 years of age, and both genders will be eligible to be part of the study. OSA and its severity will be diagnosed by a preoperative polysomnography.

Exclusion Criteria:

  • Children with compromised cardiovascular, pulmonary or renal function, those with congenital syndromes, sickle cell disease, history of seizures and those receiving theophylline will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349205

Locations
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Memorial Hermann Hospital
Investigators
Principal Investigator: samia Khalil, MD Memorial Hermann Hospital
  More Information

Responsible Party: Samia Khalil, Professor - Anesthesiology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01349205     History of Changes
Other Study ID Numbers: HSC-MS-09-0457  HSC-MS-09-0457 
Study First Received: May 3, 2011
Last Updated: December 11, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
OSA
Caffeine
Tonsillectomy
Adenoidectomy
Sleep Study

Additional relevant MeSH terms:
Apnea
Hypertrophy
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Pathological Conditions, Anatomical
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Caffeine
Caffeine, sodium benzoate drug combination
Sodium Benzoate
Analgesics
Analgesics, Non-Narcotic
Anti-Infective Agents
Antifungal Agents
Antimutagenic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 01, 2016