NCT02409693

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2015

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

March 30, 2015

Last Update Submit

October 26, 2016

Conditions

Otitis Media With Effusion (OME)

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain scores

    Wong-Baker FACES and/or the Face, Legs, Activity, Cry, Consolability (FLACC) pain scores

    1 hr post-op

Secondary Outcomes (2)

  • Presence of emergence delirium

    1 hr post-op

  • Post-operative nausea & vomiting

    1 hr post-op

Study Arms (1)

Myringotomy with tube insertion

Patients who received surgically inserted ear tubes.

Procedure: Myringotomy with tube insertion

Interventions

Myringotomy with tube insertionPROCEDURE
Also known as: BTI
Myringotomy with tube insertion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Otitis Media with Effusion

Interventions

Middle Ear Ventilation

Condition Hierarchy (Ancestors)

Otitis MediaOtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

OstomySurgical Procedures, OperativeOtologic Surgical ProceduresOtorhinolaryngologic Surgical Procedures

Study Officials

  • Richard Cartabuke, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director Outpatient Anesthesia Services

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 7, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10