- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01349205
Caffeine in Children With Obstructive Sleep Apnea, Dose Response Study
May 12, 2016 updated by: Samia Khalil, The University of Texas Health Science Center, Houston
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.
Study Overview
Status
Terminated
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.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Memorial Hermann Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Caffeine and Sodium Benzoate 10 mg/kg IV
Group 1 of randomized study.
|
IV, 10mg/kg, IVP, 1 time
|
Experimental: Caffeine and Sodium Benzoate 20 mg/kg IV
Group 2 of randomized study
|
IV, 20 mg/kg, IVP, 1 time
|
Placebo Comparator: 0.9 NS Saline
Control group of randomized study.
|
IV, 0-10 ml, IVP, 1 time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of Caffeine
Time Frame: Immediately after drug administration upto 24 hours
|
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 )
|
Immediately after drug administration upto 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caffeine Drug Effects
Time Frame: Immediately after drug administration to 24 hours
|
A secondary outcome of the study will be the incidence of adverse post-extubation respiratory events.
|
Immediately after drug administration to 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: samia Khalil, MD, Memorial Hermann Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
May 3, 2011
First Submitted That Met QC Criteria
May 5, 2011
First Posted (Estimate)
May 6, 2011
Study Record Updates
Last Update Posted (Estimate)
May 13, 2016
Last Update Submitted That Met QC Criteria
May 12, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Apnea
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Purinergic Antagonists
- Purinergic Agents
- Protective Agents
- Antifungal Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Central Nervous System Stimulants
- Antimutagenic Agents
- Caffeine
- Sodium Benzoate
- Caffeine, sodium benzoate drug combination
Other Study ID Numbers
- HSC-MS-09-0457 (Other Identifier: Memorial Hermann CPHS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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