Pain Management in Corneal Collagen Crosslinking for Keratoconus

Study Overview
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Brief Summary
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This is a prospective, randomized, single blind study. Patients enrolled in the study were randomly assigned to a ketorolac or a gabapentin group for pain control. Different pain scores and variables will be evaluated, along with others side effects variables.

Detailed Description
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This is a prospective, randomized, single blind study. Patients enrolled in the study were randomly assigned to the ketorolac or gabapentin group. The gabapentin (Neurontin, Pfizer, Mexico) group was instructed to take one 300-mg capsule the night before surgery and 1 capsule every 8 hours on the day of surgery and for the first 3 postoperative days. The ketorolac group (Dolac, Siegfried Rhein, Mexico) was instructed to take their 10-mg tablets every 8 hours on the day of surgery and for the first 3 postoperative days. Different pain scores and variables will be evaluated, along with others side effects variables.

Official Title
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Pain Management in Corneal Collagen Crosslinking for Keratoconus: Prospective Randomized Study

Conditions
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Pain

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Ketorolac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with keratoconus older than 18 years with documented bilateral keratometric progression in the previous 6 to 12 months. Exclusion Criteria: Previous ocular or systemic diseases that could affect epithelial healing; use of topical or systemic non-steroidal anti-inflammatory drugs, or chronic use of any other pain medication, pregnancy and allergy to the drugs of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Corneal collagen CXL epi-off<br>For the epithelium-off procedure, the corneal epithelium is removed with a 10-minute soak time with isotonic riboflavin 0.1% solution and 4 minutes of exposure with 30 mw/cm2 ultraviolet-A irradiation. | Drug: Gabapentin<br>* The gabapentin (Neurontin, Pfizer, Mexico) group was instructed to take one 300-mg capsule the night before surgery and 1 capsule every 8 hours on the day of surgery and for the first 3 postoperative days.<br>* Other names: Neurontin;Drug: Ketorolac<br>* The ketorolac group (Dolac, Siegfried Rhein, Mexico) was instructed to take their 10-mg tablets every 8 hours on the day of surgery and for the first 3 postoperative days.<br>* Other names: Dolac;|
| Other: Corneal collagen CXL epi-on<br>For the epithelium-on procedure, riboflavin is applied for a total soak of 4 minutes; the cornea is then completely rinsed with additional riboflavin for a total of 6 minutes. The ultraviolet-A irradiation is performed for 2 minutes and 40 seconds at 45mw/cm2. | Drug: Gabapentin<br>* The gabapentin (Neurontin, Pfizer, Mexico) group was instructed to take one 300-mg capsule the night before surgery and 1 capsule every 8 hours on the day of surgery and for the first 3 postoperative days.<br>* Other names: Neurontin;Drug: Ketorolac<br>* The ketorolac group (Dolac, Siegfried Rhein, Mexico) was instructed to take their 10-mg tablets every 8 hours on the day of surgery and for the first 3 postoperative days.<br>* Other names: Dolac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric scale of pain | Using a numeric scale of pain, patients were asked to state their pain intensity on a scale of 0 to 10, explaining the patient that a 0 represents no pain at all and a 10 would be the worst pain imaginable. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | The last four issues on the questionnaire were related to side effects associated with the use of the medication, specifically dizziness, drowsiness, headaches, and gastrointestinal symptoms | 5 days | 
| Symptoms related to pain | Patients were asked to rate the severity of four different symptoms during the 24-hour period prior to follow-up: tearing, light sensitivity, foreign body sensation, and discomfort/irritation | 5 days |