Adenoidectomy, Functional Endoscopic Sinus Surgery (FESS), Turbinate Surgery
Conditions
Brief summary
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.
Interventions
DRUGOxymetazoline
Sponsors
Richard Cartabuke
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients that are scheduled for: 1. Functional endoscopic sinus surgery 2. Turbinate reduction (with or without tonsillectomy and/or adenoidectomy) 3. Adenoidectomy
Exclusion criteria
* Been treated with oral decongestants or antihistamines within 24 hours of surgery * Are taking anticoagulants * Have a history of nasal trauma * Have a history of epistaxis * Have a history of hypertension or cardiac disease * Allergy to oxymetazoline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Following Oxymetazoline Administration | 5 - 150 mins. after 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. |
| Heart Rate Following Oxymetazoline Administration. | 5 - 150 mins. after 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Hemostasis | intraoperative | A six point scale (very easy, easy, usual, some effort, difficult, extremely difficult) completed by the surgeon at the end of surgery. |
| Amount of Bleeding | intraoperative | A four point scale (none, minimal, moderate/diffuse ooze, severe/brisk) completed by the surgeon after removal of the oxymetazoline soaked pledgets. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Children Undergoing ENT Surgery Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
| Overall Study | Unable to obtain blood samples | 2 |
Baseline characteristics
| Characteristic | Children Undergoing ENT Surgery | — |
|---|---|---|
| Age, Categorical <=18 years | 30 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Age, Continuous | 7 years STANDARD_DEVIATION 4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 22 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
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.
Time frame: 5 - 150 mins. after administration
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Children Undergoing ENT Surgery | Blood Pressure Following Oxymetazoline Administration | Systolic blood pressure | 102 mmHg | Standard Deviation 16 |
| Children Undergoing ENT Surgery | Blood Pressure Following Oxymetazoline Administration | Diastolic blood pressure | 53 mmHg | Standard Deviation 17 |
| Children Undergoing ENT Surgery | Blood Pressure Following Oxymetazoline Administration | Mean arterial pressure | 65 mmHg | Standard Deviation 15 |
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.
Time frame: 5 - 150 mins. after administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Children Undergoing ENT Surgery | Heart Rate Following Oxymetazoline Administration. | 98 beats per minute | Standard Deviation 22 |
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.
Time frame: intraoperative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Children Undergoing ENT Surgery | Amount of Bleeding | None | 11 Participants |
| Children Undergoing ENT Surgery | Amount of Bleeding | Minimal | 11 Participants |
| Children Undergoing ENT Surgery | Amount of Bleeding | Moderate | 5 Participants |
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.
Time frame: intraoperative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Children Undergoing ENT Surgery | Ease of Hemostasis | Very Easy | 10 Participants |
| Children Undergoing ENT Surgery | Ease of Hemostasis | Easy | 9 Participants |
| Children Undergoing ENT Surgery | Ease of Hemostasis | Usual | 8 Participants |