Otitis Media With Effusion (OME) Clinical Trial
| Verified date | October 2016 |
| Source | Nationwide Children's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Patients who underwent myringotomy with tube insertion from January 1, 2015 through February 28, 2015 at NCH. Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Nationwide Children's Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Post-operative pain scores | Wong-Baker FACES and/or the Face, Legs, Activity, Cry, Consolability (FLACC) pain scores | 1 hr post-op | No |
| Secondary | Presence of emergence delirium | Agitation when awakening from anesthesia | 1 hr post-op | No |
| Secondary | Post-operative nausea & vomiting | Incidence of nausea and vomiting in the post-anesthesia care unit (PACU) | 1 hr post-op | No |