The Effect of Dexamethasone Dosing on Post-tonsillectomy... | NCT02228135

Studies
The Effect of Dexamethasone Dosing on Post-tonsillectomy Hemorrhage

NCT02228135

Sponsor

Nicole Elsey

Status

Completed

Last Update Posted

Jul 26, 2017Actual

Enrollment

9,843Actual

Phase

Not provided

Conditions

Tonsillectomy
Adenotonsillectomy

Interventions

Dexamethasone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Feb 2017Actual

Completion Date

Feb 2017Actual

First Submitted Date

Aug 27, 2014

First Submission Date that Met QC Criteria

Aug 27, 2014

First Posted Date

Aug 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2017

Last Update Posted Date

Jul 26, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a retrospective chart review looking at the effect of dexamethasone dosing on post-tonsillectomy hemorrhage.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9,843Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non post-tonsillectomy hemorrhage		Children who do not have post-tonsillectomy hemorrhage.	Drug: Dexamethasone
Post-tonsillectomy hemorrhage		Children return to the hospital after surgery with post-tonsillectomy hemorrhage.	Drug: Dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug		Non post-tonsillectomy hemorrhage Post-tonsillectomy hemorrhage

Measure	Description	Time Frame
Dexamethasone Dosage		once at start of surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing a tonsillectomy
Patients undergoing an adenotonsillectomy

Exclusion Criteria:

All patients with a known history of bleeding or clotting disorders, as well as those patients who had presented to Nationwide Children's Hospital main operating room for control of PTH but had their initial tonsillectomy/adenotonsillectomy at an outlying facility will be excluded from the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Children who have had tonsillectomy or adenotonsillectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

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Browse Branches

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