In a randomized double blind clinical trial to study on number 80 patients with ASA class I And II scheduled for elective PRK surgery .inclusion criteria for patient consent to perform PRK and consent to participate in the study.
Exclusion criteria included corneal injuries and allergic to medicine and unwillingness to participate in the study. 30 minutes before surgery one group take 50 mg pregabaline PO and other group take placebo tablet with a glass of water .Patients undergoing surgery by a surgeon and a Method photo refractive keratectomy (PRK). At the end of surgery before discharge, 6 h, 12 h, 48 h and 72 h after surgery, the patients' pain using a visual index of pain (VAS) visual analogue scale is measured and recorded. The results are under analysis and review
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109231617N5
Registration date:2012-05-21, 1391/03/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-21, 1391/03/01
Registrant information
Name
Mansour Choubsaz
Name of organization / entity
Imam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 83 1724 6708
Email address
mchoubsaz@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences and health Services
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study in The effect of single dose pregabaline in reducing postoperative pain following photo refractive keratectomy (PRK)
Public title
The effect of single dose pregabaline in reducing postoperative pain following photo refractive keratectomy (PRK)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria for patient consent to perform PRK and consent to participate in the study.
Exclusion criteria included corneal injuries and allergic to medicine and unwillingness to participate in the study
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Kermanshah University of Medical Sciences
Street address
Pro-Vice-Chancellor for Research, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2012-02-05, 1390/11/16
Ethics committee reference number
61015
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
H57.1
ICD-10 code description
Ocular pain
Primary outcomes
1
Description
Pain
Timepoint
72 houres after dischurge
Method of measurement
Visual analogue score
Secondary outcomes
1
Description
Analgesic use
Timepoint
72 houres after dischurge
Method of measurement
Calculating dosage
Intervention groups
1
Description
Pregabalin 50 mg oral tablet with a glass of water
30 minutes before surgery
Category
Prevention
2
Description
Placebo oral tablet with a glass of water
30 minutes before surgery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Dr. Farid Najafi
Street address
Pro-Vice-chancellor for research, Kermanshah University of Medical Sciences
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences and health Services
Full name of responsible person
Mohamad Reza Nikbakhat
Street address
Kermanshah University of Medical Sciences and health Services
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences and health Services
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
Imam Reza Hospital
Full name of responsible person
Tayebeh kazerooni
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Departement of Anesthesia and intensive care, Imam Reza Hospital
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Mansour Choubsaz
Position
Anesthesiologist/Assisstant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences and Health Services
City
Kermanshah
Postal code
6718938179 00988317
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Mansour Choubsaz
Position
Anesthesiologist/Assistant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences and Heaith Services
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 72 44969
Email
mchoobsaz@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)