The Antigagging Effect of Granisetron (Kytril), an Antiemetic Drug, in Dental Situations
NCT ID: NCT00502437
Last Updated: 2010-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
INTERVENTIONAL
Brief Summary
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Gagging in dental situations can be a problem to the patient and the operating dentist. There are not proven methods of eliminating this reflex which sometimes will not allow routine quality dental care.
Pharmacological and behavioral approaches to eliminate this reflex have been tried with limited success.
This suggested study will test a potent antiemetic drug used in other clinical situations such as antineoplastic treatment. Granisetron is a potential antagonist for the 5-hydroxytryptamine3-receptor - 5HT(3), The drug binds to the receptor and blocks the effect of nausea and vomiting. Kytril mechanism of action was successfully proven for various medical situations as a potential antiemetic agent. Our Center for dental sedation and anesthesia in the oral medicine department have received approval to use Granisetron as an antigagging drug in dental situations based on several pilot studies conducted in other medical centers in different clinical situations such as strabismus corrections, post hysterectomy and others. Our preliminary clinical impression is that pre-emptive IV administration of this drug to patients with increased gag reflex is beneficial.
In our research we try to investigate the possibility of using kytril in dental situations.
In the first stage of this research we will study the INTRAVENOUS use of this drug and its effects On normal subjects compare them to themselves with placebo. According to the results of this study we will go on to the second stage of the research and try the same drug under oral administration.
The purpose of this study is to test the antigagging effect of this drug in a controlled manner in dental situations.
Our working hypothesis is that administration of this drug in dental situations with success, will allow many patients to receive good dental care
Detailed Description
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Conditions
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Study Design
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CROSSOVER
DOUBLE
Interventions
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GRANISETRON
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* subjects under medication or drug or food complementary agents
18 Years
50 Years
ALL
Yes
Sponsors
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Hadassah Medical Organization
OTHER
Principal Investigators
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Eliezer Kaufman, DMD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Locations
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Hadassah Medical Organization
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Arik Tzukert, DMD
Role: primary
Hadas Lemberg, PhD
Role: backup
Other Identifiers
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376-11.05.07HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id