Pain Management in Corneal Collagen Crosslinking for Keratoconus

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Gabapentin; Drug: Ketorolac

Detailed Description

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
• Enrollment (Actual): 25
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Corneal collagen CXL epi-off; 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; 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.; Other Names: Neurontin; Drug: Ketorolac; 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.; Other Names: Dolac
Other: Corneal collagen CXL epi-on; 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; 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.; Other Names: Neurontin; Drug: Ketorolac; 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.; Other Names: Dolac

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
• Investigators: Study Chair: Enrique Graue-Hernandez, Md, MSc, INSTITUTO DE OFTALMOLOGIA CONDE DE VALENCIANA

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Estimate): August 15, 2016
• Last Update Submitted That Met QC Criteria: August 10, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin; Ketorolac
• Other Study ID Numbers: CXL-PAIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO