This study was designed to evaluate the safety and efficacy of oral tramadol in patients undergoing colonoscopy. A total of 90 patients scheduled for colonoscopy referred to Mahdieh clinic of Kermanshah University of Medical Sciences , After obtaining informed consent, Randomly divided into two groups:Recipient of a tablet 100mg of teramadol, 4 hour before colonoscopy and The control group did not receive tramadol, they only receive a multivitamin. the patients undergoing colonoscopy. Blinding was done for the patient and the person performing the colonoscopy . Measurable outcomes about Safety and efficacy include physician satisfaction,Sweating and restlessness,Muscle movements,The sound produced by the patient,recovery duration,Discharge,Nausea and vomiting that Recorded for each patient .By application of statistical analysis , comparisons between the two groups was done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010820610N1
Registration date:2015-02-22, 1393/12/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-22, 1393/12/03
Registrant information
Name
Teymor Kamari
Name of organization / entity
Kermanshah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 4434
Email address
t.kamari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the safety and efficacy of oral Tramadol in patients undergoing colonoscopy
Public title
Evaluate the safety and efficacy of oral Tramadol in patients undergoing colonoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age between 20 to 65 years, for whatever reason are candidates for colonoscopy.
Exclusion criteria: People who have a history of drug abuse,People who have drug allergies, Heart disease, Or chronic systemic diseases.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti.Blv,
City
Kermanshah
Postal code
Approval date
2014-09-02, 1393/06/11
Ethics committee reference number
23311
Health conditions studied
1
Description of health condition studied
Diseases of the digestive system
ICD-10 code
K90-K93
ICD-10 code description
Other diseases of the digestive system
Primary outcomes
1
Description
pain density
Timepoint
During colonoscopy
Method of measurement
Visual Analogue Scale for pain
Secondary outcomes
1
Description
Safety and efficacy of oral tramadol on pain
Timepoint
During colonoscopy
Method of measurement
Visual Analogue Scale for pain
Intervention groups
1
Description
Intervention: oral Tramadol
One pill of oral Tramadol , 4 hours before colonoscopy
Category
Treatment - Drugs
2
Description
Control group: Multivitamin
One pill of oral Multivitamin , 4 hours before colonoscopy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh clinic
Full name of responsible person
Teymor kamari
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Kermanshah University Of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Shahid Beheshti Blv, Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Kermanshah 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
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Teymor kamari
Position
Resident of internal medicine
Other areas of specialty/work
Street address
Imam Reza hospital
City
Kermanshah
Postal code
Phone
+98 83 3427 6309
Fax
Email
t.kamari@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mehdi Zobeiri
Position
Gastroenterologist
Other areas of specialty/work
Street address
Imam Reza hospital
City
Kermanshah
Postal code
Phone
+98 83 3427 6309
Fax
Email
m.zobeiri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Teymor kamari
Position
Resident of internal medicine
Other areas of specialty/work
Street address
Imam Reza hospital
City
Kermanshah
Postal code
Phone
+98 83 3427 6309
Fax
Email
t.kamaei@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)