Dental AnesthesiaPhase 2NCT02062996
Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption
A Phase 2 study testing Oxymetazoline in people with Dental Anesthesia and Nasal Surgical Procedures, run by Richard Cartabuke at 1 site in United States.
Trial summary
Oxymetazoline is an α-adrenergic agonist that is commonly used as a topical sympathomimetic agent in over-the-counter decongestant sprays. It is used extensively at Nationwide Children's Hospital for surgical procedures to produce vasoconstriction and reduce bleeding. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Dental Anesthesia, Nasal Surgical Procedures, Intranasal Drug Administration
- What is being tested?
- Oxymetazoline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients ages 2 through 12 yrs.
- Scheduled for: operative dentistry, functional endoscopic sinus surgery, or turbinate reduction (with or without tonsillectomy and/or adenoidectomy).
Who cannot join
- Treatment with oral decongestants or antihistamines within 24 hours of surgery.
- Taking anticoagulants.
- History of nasal trauma.
- History of epistaxis (nose bleeds).
- 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: The Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption During Functional Endoscopic or Turbinate Reduction Surgery and From the Nasal Mucosa During Operative Dentistry
Oxymetazoline is an α-adrenergic agonist that is commonly used as a topical sympathomimetic agent in over-the-counter decongestant sprays. It is used extensively at Nationwide Children's Hospital for surgical procedures to produce vasoconstriction and reduce bleeding. Although there is generally limited vascular absorption, when administered in larger doses, uptake of oxymetazoline can lead to significant systemic hemodynamic effects. The NCH anesthesia department recently reported a case of oxymetazoline induced postoperative hypertension in a three-year-old child following inferior turbinate reduction and adenoidectomy. Current practice at NCH is to soak pledgets with full strength oxymetazoline and insert a varying number of pledgets during surgical procedures or instill oxymetazoline drops into the nose prior to nasotracheal intubation. There is no pediatric data regarding the method of administration and the absorption of oxymetazoline or the dose-response relationship of oxymetazoline serum levels on blood pressure and heart rate. These studies would be the first to determine safe and appropriate doses of oxymetazoline in the pediatric population.
- 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 |
|---|---|---|
| ENT - full strength | Experimental | Full strength oxymetazoline pledgets packed in the nose (total volume 20 ml). Receives: Drug: Oxymetazoline |
| ENT - 1/2 strength | Experimental | ½ strength oxymetazoline pledgets packed in the nose (total volume 20 ml). Receives: Drug: Oxymetazoline |
| DENTAL - Full strength 1.0 mL | Experimental | Full strength oxymetazoline 1.0 mL to each naris (total =1000 mcg). Receives: Drug: Oxymetazoline |
| DENTAL - Full strength 0.5 mL | Experimental | Full strength oxymetazoline 0.5 mL to each naris (total = 500 mcg). Receives: Drug: Oxymetazoline |
| DENTAL - ½ strength 0.5 mL | Experimental | ½ strength oxymetazoline 0.5 mL to each naris (total = 250 mcg). Receives: Drug: Oxymetazoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxymetazoline plasma concentration
Measured: 5, 10, 20, 45, 90 & 150 mins. after dosing
Secondary outcomes (2)
Heart rate
Assessing for bradycardia
Measured: Every 2-5 mins. for a maximum of 240 mins.
Blood pressure
Assessing for hypertension.
Measured: Every 2-5 mins. for a maximum of 240 mins.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Could not receive FDA approval for IND
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnesthesiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT02062996
- Sponsor's protocol ID
- IRB14-00016
- Status last verified
- Aug 2015
- First submitted
- 12 Feb 2014
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption During Functional Endoscopic or Turbinate Reduction Surgery and From the Nasal Mucosa During Operative Dentistry
- ClinicalTrials.gov ID
- NCT02062996
- Acronym / sponsor ID
- IRB14-00016
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not receive FDA approval for IND
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Richard CartabukeUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oxymetazoline is an α-adrenergic agonist that is commonly used as a topical sympathomimetic agent in over-the-counter decongestant sprays. It is used extensively at Nationwide Children's Hospital for surgical procedures to produce vasoconstriction and reduce bleeding. Although there is generally limited vascular absorption, when administered in larger doses, uptake of oxymetazoline can lead to significant systemic hemodynamic effects. The NCH anesthesia department recently reported a case of oxymetazoline induced postoperative hypertension in a three-year-old child following inferior turbinate reduction and adenoidectomy. Current practice at NCH is to soak pledgets with full strength oxymetazoline and insert a varying number of pledgets during surgical procedures or instill oxymetazoline drops into the nose prior to nasotracheal intubation. There is no pediatric data regarding the method of administration and the absorption of oxymetazoline or the dose-response relationship of oxymetazoline serum levels on blood pressure and heart rate. These studies would be the first to determine safe and appropriate doses of oxymetazoline in the pediatric population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ENT - full strength | Experimental | Drug: OxymetazolineFull strength oxymetazoline pledgets packed in the nose (total volume 20 ml). |
| ENT - 1/2 strength | Experimental | Drug: Oxymetazoline½ strength oxymetazoline pledgets packed in the nose (total volume 20 ml). |
| DENTAL - Full strength 1.0 mL | Experimental | Drug: OxymetazolineFull strength oxymetazoline 1.0 mL to each naris (total =1000 mcg). |
| DENTAL - Full strength 0.5 mL | Experimental | Drug: OxymetazolineFull strength oxymetazoline 0.5 mL to each naris (total = 500 mcg). |
| DENTAL - ½ strength 0.5 mL | Experimental | Drug: Oxymetazoline½ strength oxymetazoline 0.5 mL to each naris (total = 250 mcg). |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients ages 2 through 12 yrs.
- Scheduled for: operative dentistry, functional endoscopic sinus surgery, or turbinate reduction (with or without tonsillectomy and/or adenoidectomy).
Key exclusion criteria (6 listed)
- Treatment with oral decongestants or antihistamines within 24 hours of surgery.
- Taking anticoagulants.
- History of nasal trauma.
- History of epistaxis (nose bleeds).
- 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 | DENTAL - Full strength 0.5 mL, DENTAL - Full strength 1.0 mL, DENTAL - ½ strength 0.5 mL, ENT - 1/2 strength, ENT - full strength |
Primary outcome
Oxymetazoline plasma concentration
Time frame: 5, 10, 20, 45, 90 & 150 mins. after dosing
2 secondary outcomes
Heart rate
Time frame: Every 2-5 mins. for a maximum of 240 mins.
Blood pressure
Time frame: Every 2-5 mins. for a maximum of 240 mins.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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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 Phase 2 study testing Oxymetazoline in people with Dental Anesthesia and Nasal Surgical Procedures, 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 2 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: withdrawn, as of the sponsor's last update on 7 Aug 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Oxymetazoline plasma concentration (time frame: 5, 10, 20, 45, 90 & 150 mins. after dosing). 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 7 Aug 2015.