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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GABAPENTIN | Experimental | Group of patients treated with oral gabapentin |
|
| PLACEBO | Placebo Comparator | Group given the placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Gabapentin PO. (300MG) 1 capsule the night before surgery, q12hrs the day of surgery and q8hrs for the firt 3 postoperative days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. | 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 | 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 | 72 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Time required for complete healing | Slit lamp observation of the epithelial defect and time until removal of contact lens. | Evaluated each day until complete healing |
| Visual acuity | Snellen Chart |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Codet Vision Institute | Tijuana | Estado de Baja California | 22320 | Mexico |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Sugar pill | Drug | Sugar pill. One capsule given the night before surgery, q12hrs on the day of surgery and q8hrs for the first 3 postoperative days. |
|
| 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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Assesed on the 7th postoperative day |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Every 24 hours until complete healing and at the 7th day postop |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002241 | Carbohydrates |