Pain After Photorefractive Keratectomy
Conditions
Keywords
Refractive surgery, PRK, PAIN, Gabapentin
Brief summary
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.
Interventions
DRUGGabapentin
Gabapentin PO. (300MG) 1 capsule the night before surgery, q12hrs the day of surgery and q8hrs for the firt 3 postoperative days.
DRUGSugar pill
Sugar pill. One capsule given the night before surgery, q12hrs on the day of surgery and q8hrs for the first 3 postoperative days.
Sponsors
Codet Vision Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must be at least 18 years of age 2. Subjects must not have any corneal disease or degeneration 3. Subjects must be candidates for LASIK or PRK refractive surgery
Exclusion criteria
1. History of topical ocular medications within 4 weeks prior to enrollment 2. History of conjunctivitis or ocular inflammation within 4 weeks prior to enrollment 3. History of a previous refractive surgery 4. History of previous diagnosis of corneal disease, degeneration, or glaucoma 5. History of autoimmune disease 6. History of oral anti-histamines currently or within 1 week of study enrollment 7. History of systemic anti-inflammatory or pain medication currently or within 4 weeks of study enrollment 8. Use of oral diuretics or betablocker currently or within 1 week of study enrollment 9. Current diagnosis of dry eye 10. Patients whose Best corrected vision is less than 20/20 11. Patients whose target post operative refraction is not plano 12. Pregnant and lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum pain intensity since the last examination | Assesed on the 7th postoperative day | 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 |
| Pain at moment of examination | 24 hours postoperatively | 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 |
| Average pain for the previous 24 hour period, | assesed at 24 hours | 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 |
| Maximum pain intensity for the previous 24 hour period | Assesed at 24 hours postoperatively | In a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded. |
| pain on examination | 72 hours postoperatively | 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 |
| Average pain for the previous 24 hour period | Assesed at 48 hours | 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 |
| Average pain during the previous 24 hour period | Assesed at 72 hours postoperatively | 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 |
| Average pain for the last 24 hours period | Assesed at 96 hours postoperatively | 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 |
| Average pain since last examination | Assesed on postopertive day 7 | 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 |
| Maximum pain intensity for the last 24 hour period | Assesed at 96 hours postoperatively | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time required for complete healing | Evaluated each day until complete healing | Slit lamp observation of the epithelial defect and time until removal of contact lens. |
| Visual acuity | every day until complete healing and at the 7th day postop | Snellen Chart |
| Foreign body sensation | Every 24 hours until complete healing and at the 7th day postop | Numerical visual scale, In a scale from 0-10 where 0 is the least amount of foreign body sensation and 10 being the most. |
| Light sensitivity | Every 24 hours until complete healing and at the 7th day postop | Numerical visual scale, in a scale from 0-10 where 0 is the least amount of light sensitibity and 10 being the most. |
| Tearing and watery eyes | Every 24 hours until complete healing and at the 7th day postop | Numerical visual scale questionaire, In a scale from 0-10 where 0 is the least amount of tearing and 10 being the most. |
| Eye discomfort | Every 24 hours until complete healing and at the 7th day postop | Numerical visual scale questionnaire, In a scale from 0-10 where 0 is the least amount of discomfort and 10 being the most. |
| Dizziness | Every 24 hours until complete healling and at the 7th day postop | Numerical visual scale, scale from 0-10 where 0 is the least dizzy and 10 being the most. |
| lethargy | Every 24 hours until complete healing and at the 7th day postop | Numerical visual scale, In a scale from 0-10 where 0 is the least lethargic and 10 is the most. |
| Headache | Every 24 hours until complete healing and at the 7th day postop | 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. |
| Gastro-intestinal symptoms | Every 24 hours until complete healing and at the 7th day postop | Numerical visual scale, In a scale from 0-10 where 0 is the least amount of symptoms and 10 being the most symptoms. |
Countries
Mexico
Outcome results
None listed