Caffeine in Children With Obstructive Sleep Apnea, Dose Response Study
| Status: | Terminated |
|---|---|
| Conditions: | Insomnia Sleep Studies, Orthopedic, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 2 - 12 |
| Updated: | 5/14/2016 |
| Start Date: | March 2010 |
| End Date: | June 2014 |
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.
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.
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.
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.
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.
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