Pain Management in Corneal Collagen Crosslinking for Keratoconus

Instituto de Oftalmología Fundación Conde de Valenciana25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Pain

Interventions

GabapentinDRUG

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.

KetorolacDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 5 days

Secondary Outcomes

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

Time frame: 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

Time frame: 5 days

Data from ClinicalTrials.gov

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