Caffeine in Children With Obstructive Sleep Apnea, Dose Response Study

The University of Texas System (UT)

Status: Terminated

Conditions: Enlargement of Tonsil or Adenoid; Obstructive Sleep Apnea

Treatments: Drug: 0.9 NS Saline; Drug: Caffeine and Sodium Benzoate 20 mg/kg IV; Drug: Caffeine and sodium Benzoate 10 mg/kg IV

Study type: Interventional

Funder types: Other

Identifiers

NCT01349205

HSC-MS-09-0457 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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42 participants in 3 patient groups, including a placebo group

Caffeine and Sodium Benzoate 10 mg/kg IV

Experimental group

Description:

Group 1 of randomized study.

Treatment:

Drug: Caffeine and sodium Benzoate 10 mg/kg IV

Caffeine and Sodium Benzoate 20 mg/kg IV

Experimental group

Description:

Group 2 of randomized study

Treatment:

Drug: Caffeine and Sodium Benzoate 20 mg/kg IV

0.9 NS Saline

Placebo Comparator group

Description:

Control group of randomized study.

Treatment:

Drug: 0.9 NS Saline