In this study 5o patients between 18 to 70 years old who are going to have a photorefractive keratotomy (PRK) will be divided into three groups in order to compare the effect of Gabapentin (Neurentin) and Pregabalin (Lyrica) in pain reduction after PRK. Patients will be given randomly one of three following drugs: 1)Gabapentin 2)Pregabalin or 3)placebo for 3 days after PRK surgery. The pain will be measured based on VAS (visual analog scale) on the day of operation and on the 3rd day (morning, evening) and then compared among three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT1138901211180N12
Registration date:2010-05-21, 1389/02/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-21, 1389/02/31
Registrant information
Name
pooya rostami
Name of organization / entity
Opthalmic Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 5952
Email address
labbafi@hotmail.com
Recruitment status
Recruitment complete
Funding source
Ophthalmic Research Center
Expected recruitment start date
2010-03-05, 1388/12/14
Expected recruitment end date
2010-10-06, 1389/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Gabapentin (Neurentin) and Pregabalin (Lyrica) in pain reduction after photorefractive keratectomy (PRK)
Public title
The effect of Gabapentin (Neurentin) and Pregabalin (Lyrica) in pain reduction after photorefractive keratectomy (PRK)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who are candidate for PRK, age between 18 to 70. Exclusion criteria: using any systemic analgesic drugs, drug intolerance, need of systemic or topical administration of NSAIDs or eye drops for allergy and glaucoma, dry eyes, pregnancy, breast feeding.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT01122004
Registration date
2010-12-04, 1389/09/13
Ethics committees
1
Ethics committee
Name of ethics committee
Ophthamic Research Center
Street address
No 23, Pasdaran Ave, 9th Boostan
City
Tehran
Postal code
166666
Approval date
2010-02-22, 1388/12/03
Ethics committee reference number
ت چ،7527
Health conditions studied
1
Description of health condition studied
Refractive errors
ICD-10 code
H52
ICD-10 code description
Disorders of refraction and accommodation
Primary outcomes
1
Description
pain
Timepoint
3rd day
Method of measurement
visual analog scale (VAS )
Secondary outcomes
empty
Intervention groups
1
Description
Intevention: Gabapentin 400mg twice a day for 3 days
Category
Treatment - Drugs
2
Description
Intevention: Pregabalin 75 mg twice a day for 3 days
Category
Treatment - Drugs
3
Description
Contrlo: placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ophthalmic Research Center
Full name of responsible person
Ali-Asghar Aghdai
Street address
No 23, Pasdaran Ave, 9th Boostan
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ophthalmic Research Center
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
Ophthalmic Rsearch Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mohammad Pakravan
Position
Ophthalmologist
Other areas of specialty/work
Street address
No 23, Pasdaran Ave, 9 th Boostan, Ophthalmic Research Center
City
Ttehran
Postal code
166666
Phone
+98 21 2259 2200
Fax
Email
labbafi@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Amir Faramarzi
Position
Ophthalmolgist
Other areas of specialty/work
Street address
N0 23, Pasdaran Ave, 9th Boostan, Ophthalmic Research Center
City
Tehran
Postal code
1666663111
Phone
+98 21 2276 6106
Fax
Email
labbafi@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pooya Rostami
Position
General physician
Other areas of specialty/work
Street address
No 23, Pasdaran Ave, 9th Boostan, Ophthalmic Research Center
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)