Caffeine in Children With Obstructive Sleep Apnea, Dose Response Study
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Purpose
The aim of this study is to evaluate whether a smaller dose of caffeine and 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 |
- 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 (entidal >60).
- 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.
| Estimated Enrollment: | 123 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | May 2012 (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 |
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| Contact: Mohammed Ali, MD | 7135006194 | mohammed.ali@uth.tmc.edu |
| Contact: Sam Li, MD | 7135006186 | Sam.k.li@uth.tmc.edu |
| United States, Texas | |
| Memorial Hermann Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Mohammed Ali, MD 713-500-6194 Mohammed.ali@uth.tmc.edu | |
| Contact: Sam Li, MD 7135006186 sam.k.li@uth.tmc.edu | |
| Principal Investigator: Samia Khalil, MD | |
| Principal Investigator: | samia Khalil, MD | Memorial Hermann Hospital |
More Information
No publications provided
| 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: | March 6, 2012 |
| 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 Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Pathological Conditions, Anatomical Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Benzoates Sodium Benzoate |
Caffeine Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Stimulants Physiological Effects of Drugs Central Nervous System Agents Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 19, 2013