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| Sponsor: | Hadassah Medical Organization |
|---|---|
| Information provided by: | Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: | NCT00502437 |
Purpose
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
| Condition | Intervention |
|---|---|
|
Antiggaging Effect Antiemetic Granisetron Gag Reflex Dental Situations |
Drug: GRANISETRON |
| Study Type: | Interventional |
| Study Design: | Double-Blind, Placebo Control, Crossover Assignment |
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Eliezer Kaufman, Professor | +972.2.6776121 | ekaufman@cc.huji.ac.il |
| Contact: Silvina Friedlander-Barenboim, DMD | +972.2.6776157 | silvina@hadassah.org.il |
| Israel | |
| Hadassah Medical Organization | |
| Jerusalem, Israel | |
| Principal Investigator: | Eliezer Kaufman, DMD | Hadassah Medical Organization |
More Information
| Study ID Numbers: | 376-11.05.07HMO-CTIL |
| Study First Received: | July 16, 2007 |
| Last Updated: | July 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00502437 History of Changes |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Physiological Effects of Drugs Gastrointestinal Agents Antiemetics Pharmacologic Actions Signs and Symptoms |
Serotonin Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Gagging Granisetron Peripheral Nervous System Agents Central Nervous System Agents |