AdenoidectomyNCT02453841
Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption
A study testing Oxymetazoline in people with Adenoidectomy and Functional Endoscopic Sinus Surgery (FESS), run by Richard Cartabuke at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Adenoidectomy, Functional Endoscopic Sinus Surgery (FESS), Turbinate Surgery
- What is being tested?
- Oxymetazoline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 20 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients that are scheduled for:
- Functional endoscopic sinus surgery
- Turbinate reduction (with or without tonsillectomy and/or adenoidectomy)
- Adenoidectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption During Functional Endoscopic or Turbinate Reduction Surgery or Adenoidectomy
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.
- Being tested
- Oxymetazoline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxymetazolineDrug
Also called Afrin
| Study group | Role | What they receive |
|---|---|---|
| FESS | Active comparator | Patients undergoing functional endoscopic sinus surgery and receiving oxymetazoline as part of their surgery. Receives: Drug: Oxymetazoline |
| Turbinates | Active comparator | Patients undergoing turbinate reduction surgery and receiving oxymetazoline as part of their surgery. Receives: Drug: Oxymetazoline |
| Adenoidectomy | Active comparator | Patients undergoing an adenoidectomy and receiving oxymetazoline as part of their surgery. Receives: Drug: Oxymetazoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 - 150 mins. after administration
Secondary outcomes (2)
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.
Measured: 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.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startDec 2015
- Primary completion20 Apr 2017
- Study completion20 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AdenoidectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard Cartabuke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Richard Cartabuke, Nationwide Children's Hospital
- Investigators
- Richard Cartabuke, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453841
- Sponsor's protocol ID
- IRB14-00723
- Status last verified
- Sep 2018
- First submitted
- 15 May 2015
- Last updated
- 18 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption During Functional Endoscopic or Turbinate Reduction Surgery or Adenoidectomy
- ClinicalTrials.gov ID
- NCT02453841
- Acronym / sponsor ID
- IRB14-00723
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Richard CartabukeUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Posted 18 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FESS | Active comparator | Drug: OxymetazolinePatients undergoing functional endoscopic sinus surgery and receiving oxymetazoline as part of their surgery. |
| Turbinates | Active comparator | Drug: OxymetazolinePatients undergoing turbinate reduction surgery and receiving oxymetazoline as part of their surgery. |
| Adenoidectomy | Active comparator | Drug: OxymetazolinePatients undergoing an adenoidectomy and receiving oxymetazoline as part of their surgery. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients that are scheduled for:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxymetazolineAlso: Afrin | Drug | Adenoidectomy, FESS, Turbinates |
Primary outcome
Blood Pressure Following Oxymetazoline Administration
Time frame: 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.
Time frame: 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.
2 secondary outcomes
Ease of Hemostasis
Time frame: intraoperative
Amount of Bleeding
Time frame: intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Cartabuke, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxymetazoline in people with Adenoidectomy and Functional Endoscopic Sinus Surgery (FESS), run by Richard Cartabuke at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Following Oxymetazoline Administration (time frame: 5 - 150 mins. after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.