CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 74 enrolled
Drug / intervention
Caffeine +1 moredrug
Likely dose
Caffeine 20 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00273754
NCT00273754Phase 2Completed

A Pilot Study to Evaluate if Caffeine Helps Children With Obstructive Sleep Apnea Recover Faster From Anesthesia, and With Less Complications After General Anesthesia for Tonsillectomy and Adenoidectomy.

The University of Texas Health Science Center, Houston·interventional·Posted Jan 9, 2006·Updated Jun 16, 2016

In Brief

A Phase 2 clinical trial evaluating Caffeine and Placebo for Sleep Apnea, Obstructive and 3 related conditions. Completed, enrolled 74 participants across 1 site.

Detailed Summary

This is a research study using caffeine in children who have an obstructive sleep apnea (OSA). OSA means children who stop breathing during their sleep due to obstruction in their airway. The purpose of this study is to determine whether caffeine when given in the vein, will wake children up faster and decrease post-anesthesia airway obstruction, as well as the safety and if the drug agrees with the child compared to a placebo (an inactive or dummy agent).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 9, 2006
Enrollment StartSep 1, 2003
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 20.5 years ago

Interventions

Caffeinedrug

Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base.

Placebodrug

Children in group two will receive an amount of normal saline equal to Caffeine