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This proposed study will assess the hemodynamic effects and measure the systemic absorption of topically applied oxymetazoline in patients undergoing functional endoscopic sinus surgery, turbinate surgery, or adenoidectomy. These patients will be receiving oxymetazoline as standard of care during the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FESS | Active Comparator | Patients undergoing functional endoscopic sinus surgery and receiving oxymetazoline as part of their surgery. |
|
| Turbinates | Active Comparator | Patients undergoing turbinate reduction surgery and receiving oxymetazoline as part of their surgery. |
|
| Adenoidectomy | Active Comparator | Patients undergoing an adenoidectomy and receiving oxymetazoline as part of their surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxymetazoline | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Following Oxymetazoline Administration | Blood pressure was recorded at 5 minute intervals until discharge from the post-anesthesia care unit (PACU) or the final blood draw (150 mins. after administration), whichever came first. | 5 - 150 mins. after administration |
| Heart Rate Following Oxymetazoline Administration. | Heart rate was recorded at 5 minute intervals until discharge from the post-anesthesia care unit (PACU) or the final blood draw (150 mins. after administration), whichever came first. | 5 - 150 mins. after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Hemostasis | A six point scale (very easy, easy, usual, some effort, difficult, extremely difficult) completed by the surgeon at the end of surgery. | intraoperative |
| Amount of Bleeding | A four point scale (none, minimal, moderate/diffuse ooze, severe/brisk) completed by the surgeon after removal of the oxymetazoline soaked pledgets. |
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Inclusion Criteria:
Patients that are scheduled for:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Cartabuke, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Children Undergoing ENT Surgery | Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Children Undergoing ENT Surgery | Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Pressure Following Oxymetazoline Administration | Blood pressure was recorded at 5 minute intervals until discharge from the post-anesthesia care unit (PACU) or the final blood draw (150 mins. after administration), whichever came first. | Posted | Mean | Standard Deviation | mmHg | 5 - 150 mins. after administration |
|
|
Until discharge from hospital, approximately 24 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Children Undergoing ENT Surgery | Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Cartabuke, MD | Nationwide Children's Hospital | 614-722-4200 | Richard.Cartabuke@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 5, 2018 | Jul 23, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010109 | Oxymetazoline |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| intraoperative |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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| Primary | Heart Rate Following Oxymetazoline Administration. | Heart rate was recorded at 5 minute intervals until discharge from the post-anesthesia care unit (PACU) or the final blood draw (150 mins. after administration), whichever came first. | Posted | Mean | Standard Deviation | beats per minute | 5 - 150 mins. after administration |
|
|
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| Secondary | Ease of Hemostasis | A six point scale (very easy, easy, usual, some effort, difficult, extremely difficult) completed by the surgeon at the end of surgery. | Posted | Count of Participants | Participants | intraoperative |
|
|
|
| Secondary | Amount of Bleeding | A four point scale (none, minimal, moderate/diffuse ooze, severe/brisk) completed by the surgeon after removal of the oxymetazoline soaked pledgets. | Posted | Count of Participants | Participants | intraoperative |
|
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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