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The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA). (OSA)

Primary Purpose

Sleep Apnea, Obstructive, Tonsillectomy, Adenoidectomy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Caffeine
Placebo
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep Apnea, Obstructive focused on measuring Obstructive Sleep Apnea (OSA), Tonsillectomy and Adenoidectomy (T&A), Postoperative Complications, Recovery

Eligibility Criteria

30 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children between 2.5-18 years old Diagnosed with obstructive sleep apnea Undergoing elective tonsillectomy and adenoidectomy Exclusion Criteria: Age below 2.5 or above 18 years

Sites / Locations

  • University of Texas, Health Science Center at Houston, Children's Memorial Hermann Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Caffeine

Arm Description

Saline

Caffeine benzoate

Outcomes

Primary Outcome Measures

Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo.
The number of children having adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the Operating Room and in the PACU was recorded.

Secondary Outcome Measures

Occurence of Post Extubatory Respiratory Adverse Events.
The overall occurance of adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the OR and in the PACU was noted.
Extubation Time.
Time from end of anesthesia until extubation.
Awakening Time
A child with a Steward Recovery Scale score of 6 is defined as awake, coughing/crying, and has purposeful movements.
Post Anesthesia Care Unit (PACU) Duration
Hospital Discharge Time
Children were discharged from the hospital when they reached the hospital discharge criteria: they were awake, had stable vital signs, were breathing adequately, had O2 saturation >95% while breathing room air, were able to swallow fluids, had no or minimal pain, and were able to ambulate without excessive nausea, vomiting, or dizziness.

Full Information

First Posted
January 4, 2006
Last Updated
May 12, 2016
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT00273754
Brief Title
The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).
Acronym
OSA
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Tonsillectomy, Adenoidectomy, Postoperative Complications
Keywords
Obstructive Sleep Apnea (OSA), Tonsillectomy and Adenoidectomy (T&A), Postoperative Complications, Recovery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Arm Title
Caffeine
Arm Type
Active Comparator
Arm Description
Caffeine benzoate
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Children in group two will receive an amount of normal saline equal to Caffeine
Primary Outcome Measure Information:
Title
Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo.
Description
The number of children having adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the Operating Room and in the PACU was recorded.
Time Frame
Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.
Secondary Outcome Measure Information:
Title
Occurence of Post Extubatory Respiratory Adverse Events.
Description
The overall occurance of adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the OR and in the PACU was noted.
Time Frame
Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.
Title
Extubation Time.
Description
Time from end of anesthesia until extubation.
Time Frame
Duration from anesthesia end until extubation time.
Title
Awakening Time
Description
A child with a Steward Recovery Scale score of 6 is defined as awake, coughing/crying, and has purposeful movements.
Time Frame
Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score.
Title
Post Anesthesia Care Unit (PACU) Duration
Time Frame
Time spent in PACU following surgical procedure prior to discharge home or hospital admission.
Title
Hospital Discharge Time
Description
Children were discharged from the hospital when they reached the hospital discharge criteria: they were awake, had stable vital signs, were breathing adequately, had O2 saturation >95% while breathing room air, were able to swallow fluids, had no or minimal pain, and were able to ambulate without excessive nausea, vomiting, or dizziness.
Time Frame
Total time from end anesthesia to discharge home

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children between 2.5-18 years old Diagnosed with obstructive sleep apnea Undergoing elective tonsillectomy and adenoidectomy Exclusion Criteria: Age below 2.5 or above 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samia N. Khalil, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas, Health Science Center at Houston, Children's Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).

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