Caffeine in Children With Obstructive Sleep Apnea, Dose Response Study

Obstructive Sleep Apnea Clinical Trial

Official title:

Caffeine in Children With Obstructive Sleep Apnea, Dose Response Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01349205
• Other study ID #: HSC-MS-09-0457
• Secondary ID: HSC-MS-09-0457
• Status: Terminated
• Phase: N/A
• First received: May 3, 2011
• Last updated: May 12, 2016
• Start date: March 2010
• Est. completion date: June 2014

Study information

• Verified date: May 2016
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Enlargement of Tonsil or Adenoid
• Hypertrophy
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Caffeine and sodium Benzoate 10 mg/kg IV
IV, 10mg/kg, IVP, 1 time
• Caffeine and Sodium Benzoate 20 mg/kg IV
IV, 20 mg/kg, IVP, 1 time
• 0.9 NS Saline
IV, 0-10 ml, IVP, 1 time

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Memorial Hermann Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of Caffeine	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	Yes
Secondary	Caffeine Drug Effects	A secondary outcome of the study will be the incidence of adverse post-extubation respiratory events.	Immediately after drug administration to 24 hours	Yes