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Caffeine in Children With Obstructive Sleep Apnea, Dose Response Study

NCT01349205 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-05-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Caffeine and sodium Benzoate 10 mg/kg IV

IV, 10mg/kg, IVP, 1 time

DRUG

Caffeine and Sodium Benzoate 20 mg/kg IV

IV, 20 mg/kg, IVP, 1 time

DRUG

0.9 NS Saline

IV, 0-10 ml, IVP, 1 time

Sponsors & Collaborators

  • Memorial Hermann Hospital

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • samia Khalil, MD · Memorial Hermann Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01349205 on ClinicalTrials.gov