N/A
N=30
Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption
Adenoidectomy · Functional Endoscopic Sinus Surgery (FESS) · Turbinate Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02453841 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Blood Pressure Following Oxymetazoline Administration — 102; 53; 65 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Oxymetazoline (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Richard Cartabuke
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Pressure Following Oxymetazoline Administration |
102; 53; 65 | — |
| PRIMARY Heart Rate Following Oxymetazoline Administration. |
98 | — |
| SECONDARY Ease of Hemostasis |
10; 9; 8 | — |
| SECONDARY Amount of Bleeding |
11; 11; 5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients that are scheduled for:
- Functional endoscopic sinus surgery
- Turbinate reduction (with or without tonsillectomy and/or adenoidectomy)
- 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
Data sourced from ClinicalTrials.gov (NCT02453841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.