The primary aims of this study are to determine if treatment with Gabapentin taken systemically (oral tablets) in patients who have photorefractive keratectomy (PRK) surgical treatments reduces post surgical neuropathic pain and discomfort. The investigators main Hypothesis is that gabapentin given prior to and after refractive surgery prevents central sensitization and local allodynia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
40
Gabapentin PO. (300MG) 1 capsule the night before surgery, q12hrs the day of surgery and q8hrs for the firt 3 postoperative days.
Sugar pill. One capsule given the night before surgery, q12hrs on the day of surgery and q8hrs for the first 3 postoperative days.
Codet Vision Institute
Tijuana, Estado de Baja California, Mexico
Pain at moment of examination
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Time frame: 24 hours postoperatively
Average pain for the previous 24 hour period,
Numerical visual scale questionnaire, a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Time frame: assesed at 24 hours
Maximum pain intensity for the previous 24 hour period
In a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded.
Time frame: Assesed at 24 hours postoperatively
Pain at moment of examination
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Time frame: 48 hours postoperatively
pain on examination
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Time frame: 72 hours postoperatively
pain on examination
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
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Time frame: 96 hours ostoiperatively
Pain at moment of examination
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Time frame: postoperative day 7
Average pain for the previous 24 hour period
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Time frame: Assesed at 48 hours
Average pain during the previous 24 hour period
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Time frame: Assesed at 72 hours postoperatively
Average pain for the last 24 hours period
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Time frame: Assesed at 96 hours postoperatively
Average pain since last examination
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Time frame: Assesed on postopertive day 7
Maximum pain intensity for the previous 24 hour period
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Time frame: Assesed at 48 hours postoperatively
Maximum pain intensity for the previous 24 hour period
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Time frame: Assesed at 72 hours postoperatively
Maximum pain intensity for the last 24 hour period
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Time frame: Assesed at 96 hours postoperatively
Maximum pain intensity since the last examination
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Time frame: Assesed on the 7th postoperative day
Time required for complete healing
Slit lamp observation of the epithelial defect and time until removal of contact lens.
Time frame: Evaluated each day until complete healing
Visual acuity
Snellen Chart
Time frame: every day until complete healing and at the 7th day postop
Foreign body sensation
Numerical visual scale, In a scale from 0-10 where 0 is the least amount of foreign body sensation and 10 being the most.
Time frame: Every 24 hours until complete healing and at the 7th day postop
Light sensitivity
Numerical visual scale, in a scale from 0-10 where 0 is the least amount of light sensitibity and 10 being the most.
Time frame: Every 24 hours until complete healing and at the 7th day postop
Tearing and watery eyes
Numerical visual scale questionaire, In a scale from 0-10 where 0 is the least amount of tearing and 10 being the most.
Time frame: Every 24 hours until complete healing and at the 7th day postop
Eye discomfort
Numerical visual scale questionnaire, In a scale from 0-10 where 0 is the least amount of discomfort and 10 being the most.
Time frame: Every 24 hours until complete healing and at the 7th day postop
Dizziness
Numerical visual scale, scale from 0-10 where 0 is the least dizzy and 10 being the most.
Time frame: Every 24 hours until complete healling and at the 7th day postop
lethargy
Numerical visual scale, In a scale from 0-10 where 0 is the least lethargic and 10 is the most.
Time frame: Every 24 hours until complete healing and at the 7th day postop
Headache
Numerical visual scale, In a scale from 0-10 where 0 is the least amount of headache and 10 being the most severe headache felt.
Time frame: Every 24 hours until complete healing and at the 7th day postop
Gastro-intestinal symptoms
Numerical visual scale, In a scale from 0-10 where 0 is the least amount of symptoms and 10 being the most symptoms.
Time frame: Every 24 hours until complete healing and at the 7th day postop