Does Caffeine Help Children With Obstructive Sleep Apnea Recover Faster From Anesthesia and With Less Complication After Tonsillectomy and Adenoidectomy? - Tabular View

Tracking Information

First Received Date ^ICMJE

January 4, 2006

Last Updated Date

January 5, 2009

Start Date ^ICMJE

September 2003

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Complication in post operative care unit (PACU), e.g., upper airway obstruction, laryngospasm, apnea, desaturation [ Time Frame: 24 hours from anesthesia end ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

- Complication in post operative care unit (PACU)
- Oxygen Saturation till patient reaches 6 on Steward Score
- Time after Anesthesia End to 6 on Steward Score
- Home complications
- Post-extubation complication in the operating room

Change History

Complete list of historical versions of study NCT00273754 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration from anesthesia end until extubation time, awakening time, PACU and DSU durations and hospital discharge time [ Time Frame: 24 hours from anesthesia end ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Duration from anesthesia end until extubation time,Awakening time,PACU and DSU durations and hospital discharge time. [ Time Frame: 24 hours from anesthesia end ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title ^ICMJE

Does Caffeine Help Children With Obstructive Sleep Apnea Recover Faster From Anesthesia and With Less Complication After Tonsillectomy and Adenoidectomy?

Official Title ^ICMJE

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

Brief 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).

Detailed Description

Patients with OSA are reported to have a higher rate of severe respiratory complications associated with upper airway obstruction during anesthesia and sedation or immediately after anesthesia. Children with OSA (especially those under three years of age, those with severe OSA, cerebral palsy or craniofacial anomalies) are at increased risks for post-operative complications, and require careful monitoring post-operatively.

Although the etiology of obstructive sleep apnea is mainly obstruction due to anatomical and neuromuscular abnormalities, we believe that a central element may contribute to OSA.

The aim of this study is to evaluate whether administration of caffeine to children with OSA, scheduled for elective T & A under general anesthesia contributes to a faster recovery, less post-operative complications, and a shorter stay in the PACU, DSU and the hospital.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Sleep Apnea, Obstructive
Tonsillectomy
Adenoidectomy
Postoperative Complications

Intervention ^ICMJE

Drug: Caffeine (Drug)

Study Arms / Comparison Groups

Placebo Comparator: Saline
Active Comparator: Caffeine benzoate

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Children between 2.5-18 years old
Diagnosed with obstructive sleep apnea
Undergoing elective tonsillectomy and adenoidectomy

Exclusion Criteria:

Tonsillectomy or adenoidectomy only
Age below 2.5 or above 18 years

Gender

Both

Ages

30 Months to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00273754

Responsible Party

Samia Khalil, M.D., University of Texas Medical School, Houston

Study ID Numbers ^ICMJE

HSC-MS-03-108

Study Sponsor ^ICMJE

The University of Texas Health Science Center, Houston

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Samia N. Khalil, MD

The University of Texas Health Science Center, Houston

Information Provided By

The University of Texas Health Science Center, Houston

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP