Retrospective Analysis of Perioperative Anesthetic Care a... | NCT02409693

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to obtain funding

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Mar 30, 2015

First Submission Date that Met QC Criteria

Apr 1, 2015

First Posted Date

Apr 7, 2015Estimated

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

Oct 26, 2016

Last Update Posted Date

Oct 27, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Richard Cartabuke, Co-Director Outpatient Anesthesia Services, Nationwide Children's HospitalPrincipal Investigator

Lead Sponsor

Nationwide Children's HospitalOTHER

Collaborators

Not provided

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. The purpose of this study is to retrospectively examine the use of perioperative analgesics on the incidence of postoperative pain and emergence delirium in patients undergoing bilateral myringotomy with tube insertion (BTI), as well as events associated with treatment including postoperative vomiting and time to discharge.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Myringotomy with tube insertion		Patients who received surgically inserted ear tubes.	Procedure: Myringotomy with tube insertion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Myringotomy with tube insertion	Procedure		Myringotomy with tube insertion	BTI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-operative pain scores	Wong-Baker FACES and/or the Face, Legs, Activity, Cry, Consolability (FLACC) pain scores	1 hr post-op

Secondary Outcomes

Measure	Description	Time Frame
Presence of emergence delirium	Agitation when awakening from anesthesia	1 hr post-op
Post-operative nausea & vomiting	Incidence of nausea and vomiting in the post-anesthesia care unit (PACU)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent myringotomy with tube insertion from January 1, 2015 through February 28, 2015 at NCH.

Exclusion Criteria:

None

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

Patients who have undergone anesthesia for surgical ear tube placement at Nationwide Children's Hospital from January 1, 2015 through February 28, 2015.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Cartabuke, MD	Nationwide Children's Hospital	Principal Investigator

Locations

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D010033	Otitis Media
D010031	Otitis
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

ID	Term
D010030	Ostomy
D013514	Surgical Procedures, Operative
D013506	Otologic Surgical Procedures
D013517	Otorhinolaryngologic Surgical Procedures