Otitis Media With Effusion (OME)NCT02409693
Retrospective Analysis of Perioperative Anesthetic Care and Analgesia Management of Patient Undergoing Bilateral Myringotomy With Tube Insertion
An observational study of Otitis Media With Effusion (OME), run by Nationwide Children's Hospital.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Otitis Media With Effusion (OME)
- What is being tested?
- Myringotomy with tube insertion
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- Patients who underwent myringotomy with tube insertion from January 1, 2015 through February 28, 2015 at NCH.
Who cannot join
- None
About this study
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.
- Conditions
- Otitis Media With Effusion (OME)
- Being tested
- Myringotomy with tube insertion
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myringotomy with tube insertionProcedure or surgery
Also called BTI
| Study group | Role | What they receive |
|---|---|---|
| Myringotomy with tube insertion | Patients who received surgically inserted ear tubes. Receives: Procedure: Myringotomy with tube insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain scores
Wong-Baker FACES and/or the Face, Legs, Activity, Cry, Consolability (FLACC) pain scores
Measured: 1 hr post-op
Secondary outcomes (2)
Presence of emergence delirium
Agitation when awakening from anesthesia
Measured: 1 hr post-op
Post-operative nausea & vomiting
Incidence of nausea and vomiting in the post-anesthesia care unit (PACU)
Measured: 1 hr post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Unable to obtain funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With Effusion (OME)Studies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Cartabuke, Nationwide Children's Hospital
- Investigators
- Richard Cartabuke, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409693
- Sponsor's protocol ID
- IRB15-00179
- Status last verified
- Oct 2016
- First submitted
- 30 Mar 2015
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Perioperative Anesthetic Care and Analgesia Management of Patient Undergoing Bilateral Myringotomy With Tube Insertion
- ClinicalTrials.gov ID
- NCT02409693
- Acronym / sponsor ID
- IRB15-00179
- Conditions
- Otitis Media With Effusion (OME)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to obtain funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myringotomy with tube insertion | – | Procedure: Myringotomy with tube insertionPatients who received surgically inserted ear tubes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- Patients who underwent myringotomy with tube insertion from January 1, 2015 through February 28, 2015 at NCH.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myringotomy with tube insertionAlso: BTI | Procedure or surgery | Myringotomy with tube insertion |
Primary outcome
Post-operative pain scores
Time frame: 1 hr post-op
Wong-Baker FACES and/or the Face, Legs, Activity, Cry, Consolability (FLACC) pain scores
2 secondary outcomes
Presence of emergence delirium
Time frame: 1 hr post-op
Post-operative nausea & vomiting
Time frame: 1 hr post-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Cartabuke, MD principal investigator
Nationwide Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media With Effusion (OME), run by Nationwide Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain scores (time frame: 1 hr post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.