Retrospective Analysis of Perioperative Anesthetic Care and Analgesia Management of Patient Undergoing Bilateral Myringotomy With Tube Insertion

October 26, 2016 updated by: Richard Cartabuke, Nationwide Children's Hospital
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Myringotomy with tube insertion
Patients who received surgically inserted ear tubes.
Procedure: Myringotomy with tube insertion
Other Names:
  • BTI

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB15-00179

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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