Antiemetic Clinical Trial
NCT number | NCT00502437 |
Other study ID # | 376-11.05.07HMO-CTIL |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | July 16, 2007 |
Last updated | November 28, 2010 |
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
Status | Not yet recruiting |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - normal subjects Exclusion Criteria: - presence of systemic disease - subjects under medication or drug or food complementary agents |
Intervention Model: Crossover Assignment, Masking: Double-Blind
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Medical Organization | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Israel,
Status | Clinical Trial | Phase | |
---|---|---|---|
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