Introduction:
Although gagging is a frequent problem that, when severe, can jeopardize the dental procedure, no single protocol is used to alleviate this phenomenon. Anti-emetic drugs, such as ondansetron, may attenuate gagging.
Methods and Materials:
In this study, ondansetron and placebo were administered oraly, in a double-blind clinical trail. Ondansetron and placebo group contains 44 healthy volunteers. Gagging levels were checked by means of abslang and recorded by 4 measurement scale before and 90 minutes after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010254224N8
Registration date:2011-01-27, 1389/11/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-27, 1389/11/07
Registrant information
Name
Nasser Kaviani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2858
Email address
kaviani@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellery for Research of Isfahan Dental College
Expected recruitment start date
2010-03-11, 1388/12/20
Expected recruitment end date
2010-08-06, 1389/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of oral ondansetron on gag reflex in soft palate and palatine tonsil
Public title
Evaluation the efficacy of oral ondansetron on gag reflex in soft palate and palatine tonsil
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion critria:
-ASA1
-No ban on taking ondansetron
-Lack of any oral lesion and Mental disorders
-signing the concent.
Exculution Criteria:
-pregnancy
-Breastfeeding
-gaserointestinal disorder
-liver failure
Age
From 15 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study has two groups of Drug, Placebo.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Dental faculty of Isfahan university of medical sciences
Street address
Hezar Jiereeb Street
City
Isfahan
Postal code
Approval date
2010-03-08, 1388/12/17
Ethics committee reference number
389032
Health conditions studied
1
Description of health condition studied
gag reflex
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
severity of gag reflex
Timepoint
Before and After Medication
Method of measurement
Gagging levels were recorded by 4-degree scale
Secondary outcomes
empty
Intervention groups
1
Description
Control : placebo ,tab
Category
Prevention
2
Description
Intervention : ondansetron,4mg,tab
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Dental College
Full name of responsible person
Fateme Sadat Ranjbaran
Street address
Isfahan dental school
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellery for Research of Isfahan Dental College, Isfahan University of Medical Sciences
Full name of responsible person
Aminallah Tavangar
Street address
Shohadaye sofe street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery for Research of Isfahan Dental College, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Dental College, Isfahan University of Medical Sciences
Full name of responsible person
Dr Naser Kaviani
Position
Doctor of Anesthesia
Other areas of specialty/work
Street address
Isfahan Dental College, Shohadaye Sofeh Street
City
Isfahan
Postal code
Phone
+98 31 1792 2858
Fax
Email
kaviani@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan dental school
Full name of responsible person
Fateme Sadat Ranjbaran
Position
Dentist
Other areas of specialty/work
Street address
Parastoo 24, Masroor ave, Abasabad street
City
Isfahan
Postal code
Phone
+98 31 1234 6240
Fax
Email
fatemernj@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)