- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00502437
The Antigagging Effect of Granisetron (Kytril), an Antiemetic Drug, in Dental Situations
Antigagging effect of kytril (granisetron) an antiemetic drug in dental situations
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
Study Overview
Status
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eliezer Kaufman, Professor
- Phone Number: +972.2.6776121
- Email: ekaufman@cc.huji.ac.il
Study Contact Backup
- Name: Silvina Friedlander-Barenboim, DMD
- Phone Number: +972.2.6776157
- Email: silvina@hadassah.org.il
Study Locations
-
-
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Jerusalem, Israel
- Hadassah Medical Organization
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Principal Investigator:
- Eliezer Kaufman, DMD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- normal subjects
Exclusion Criteria:
- presence of systemic disease
- subjects under medication or drug or food complementary agents
Study Plan
How is the study designed?
Design Details
- Interventional Model: Crossover Assignment
- Masking: Double
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eliezer Kaufman, DMD, Hadassah Medical Organization
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 376-11.05.07HMO-CTIL
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