Trial Outcomes & Findings for Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption (NCT NCT02453841)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

5 - 150 mins. after administration

Results posted on

2018-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	Children Undergoing ENT Surgery Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Children Undergoing ENT Surgery Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
Overall Study Protocol Violation	1
Overall Study Unable to obtain blood samples	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Children Undergoing ENT Surgery n=30 Participants Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
Age, Categorical <=18 years	30 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants
Age, Continuous	7 years STANDARD_DEVIATION 4 • n=30 Participants
Sex: Female, Male Female	8 Participants n=30 Participants
Sex: Female, Male Male	22 Participants n=30 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Children Undergoing ENT Surgery n=27 Participants Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
Blood Pressure Following Oxymetazoline Administration Systolic blood pressure	102 mmHg Standard Deviation 16
Blood Pressure Following Oxymetazoline Administration Diastolic blood pressure	53 mmHg Standard Deviation 17
Blood Pressure Following Oxymetazoline Administration Mean arterial pressure	65 mmHg Standard Deviation 15

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Children Undergoing ENT Surgery n=27 Participants Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
Heart Rate Following Oxymetazoline Administration.	98 beats per minute Standard Deviation 22

SECONDARY outcome

Timeframe: intraoperative

A six point scale (very easy, easy, usual, some effort, difficult, extremely difficult) completed by the surgeon at the end of surgery.

Outcome measures

Outcome measures
Measure	Children Undergoing ENT Surgery n=27 Participants Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
Ease of Hemostasis Very Easy	10 Participants
Ease of Hemostasis Easy	9 Participants
Ease of Hemostasis Usual	8 Participants

SECONDARY outcome

Timeframe: intraoperative

A four point scale (none, minimal, moderate/diffuse ooze, severe/brisk) completed by the surgeon after removal of the oxymetazoline soaked pledgets.

Outcome measures

Outcome measures
Measure	Children Undergoing ENT Surgery n=27 Participants Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
Amount of Bleeding None	11 Participants
Amount of Bleeding Minimal	11 Participants
Amount of Bleeding Moderate	5 Participants

Adverse Events

Children Undergoing ENT Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard Cartabuke, MD

Nationwide Children's Hospital

Phone: 614-722-4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place