Pain Management in Corneal Collagen Crosslinking for Keratoconus

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867176
• Other study ID #: CXL-PAIN
• Status: Completed
• Phase: Phase 4
• First received: August 3, 2016
• Last updated: August 10, 2016
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Instituto de Oftalmología Fundación Conde de Valenciana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Keratoconus
• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No