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Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

Sponsor
Richard Cartabuke (Other)
Overall Status
Completed
CT.gov ID
NCT02453841
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
16.6
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption During Functional Endoscopic or Turbinate Reduction Surgery or Adenoidectomy
Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Apr 20, 2017
Actual Study Completion Date :
Apr 20, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: FESS

Patients undergoing functional endoscopic sinus surgery and receiving oxymetazoline as part of their surgery.

Drug: Oxymetazoline
Other Names:
  • Afrin

    		•
    Active Comparator: Turbinates

    Patients undergoing turbinate reduction surgery and receiving oxymetazoline as part of their surgery.

    Drug: Oxymetazoline
    Other Names:
  • Afrin

    		•
    Active Comparator: Adenoidectomy

    Patients undergoing an adenoidectomy and receiving oxymetazoline as part of their surgery.

    Drug: Oxymetazoline
    Other Names:
  • Afrin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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 Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nationwide Children's Hospital Columbus Ohio United States 43205

    Sponsors and Collaborators

    • Richard Cartabuke

    Investigators

    • Principal Investigator: Richard Cartabuke, MD, Nationwide Children's Hospital

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Richard Cartabuke, Co-Director of Outpatient Anesthesia Services, Nationwide Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT02453841
    Other Study ID Numbers:
    • IRB14-00723
    First Posted:
    May 27, 2015
    Last Update Posted:
    Sep 18, 2018
    Last Verified:
    Sep 1, 2018
    Additional relevant MeSH terms:
    Phenylephrine
    Oxymetazoline

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Children Undergoing ENT Surgery
    Arm/Group Description Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
    Period Title: Overall Study
    STARTED 30
    COMPLETED 27
    NOT COMPLETED 3

    Baseline Characteristics

    Arm/Group Title Children Undergoing ENT Surgery
    Arm/Group Description Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
    Overall Participants 30
    Age (Count of Participants)
    <=18 years
    30
    100%
    Between 18 and 65 years
    0
    0%
    >=65 years
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    7
    (4)
    Sex: Female, Male (Count of Participants)
    Female
    8
    26.7%
    Male
    22
    73.3%
    Race and Ethnicity Not Collected (Count of Participants)

    Outcome Measures

    1. Primary Outcome
    Title Blood Pressure Following Oxymetazoline Administration
    Description 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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Children Undergoing ENT Surgery
    Arm/Group Description Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
    Measure Participants 27
    Systolic blood pressure
    102
    (16)
    Diastolic blood pressure
    53
    (17)
    Mean arterial pressure
    65
    (15)
    2. Primary Outcome
    Title Heart Rate Following Oxymetazoline Administration.
    Description 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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Children Undergoing ENT Surgery
    Arm/Group Description Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
    Measure Participants 27
    Mean (Standard Deviation) [beats per minute]
    98
    (22)
    3. Secondary Outcome
    Title Ease of Hemostasis
    Description 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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Children Undergoing ENT Surgery
    Arm/Group Description Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
    Measure Participants 27
    Very Easy
    10
    33.3%
    Easy
    9
    30%
    Usual
    8
    26.7%
    4. Secondary Outcome
    Title Amount of Bleeding
    Description 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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Children Undergoing ENT Surgery
    Arm/Group Description Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
    Measure Participants 27
    None
    11
    36.7%
    Minimal
    11
    36.7%
    Moderate
    5
    16.7%

    Adverse Events

    Time Frame Until discharge from hospital, approximately 24 hours.
    Adverse Event Reporting Description
    Arm/Group Title Children Undergoing ENT Surgery
    Arm/Group Description Pediatric patients undergoing functional endoscopic sinus surgery (FESS), turbinate surgery, adenoidectomy or a combination of any of these.
    All Cause Mortality
    Children Undergoing ENT Surgery
    Affected / at Risk (%) # Events
    Total 0/30 (0%)
    Serious Adverse Events
    Children Undergoing ENT Surgery
    Affected / at Risk (%) # Events
    Total 0/30 (0%)
    Other (Not Including Serious) Adverse Events
    Children Undergoing ENT Surgery
    Affected / at Risk (%) # Events
    Total 0/30 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Richard Cartabuke, MD
    Organization Nationwide Children's Hospital
    Phone 614-722-4200
    Email Richard.Cartabuke@nationwidechildrens.org
    Responsible Party:
    Richard Cartabuke, Co-Director of Outpatient Anesthesia Services, Nationwide Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT02453841
    Other Study ID Numbers:
    • IRB14-00723
    First Posted:
    May 27, 2015
    Last Update Posted:
    Sep 18, 2018
    Last Verified:
    Sep 1, 2018