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The Effect of Gabapentin (Neurentin) and Pregabalin (Lyrica) in Pain Reduction After Photorefractive Keratectomy (PRK)

Primary Purpose

Refractive Errors

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Pregabalin
Pregabalin
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Errors

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • patients candidate for PRK, 17<age<70

Exclusion Criteria:

  • use of any systemic analgesic drugs, drug intolerance, need of systemic or topical administration of NSAIDs or eye drops for allergy and glaucoma, dry eyes, pregnancy, breast feeding

Sites / Locations

  • Ophthalmic Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Gabapentin

Pregabalin

Arm Description

Outcomes

Primary Outcome Measures

pain degree based on visual analog scale(VAS)

Secondary Outcome Measures

Full Information

First Posted
April 12, 2010
Last Updated
May 10, 2010
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01122004
Brief Title
The Effect of Gabapentin (Neurentin) and Pregabalin (Lyrica) in Pain Reduction After Photorefractive Keratectomy
Acronym
PRK
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

5. Study Description

Brief Summary
The studied patients will be given randomly one of three following drugs1:Gabapentin2: Pregabalin or placebo for 3 days after Photorefractive keratectomy surgery. The pain will be measured based on visual analog scale(VAS) on the day of operation and on the 3 rd day (morning, evening) and then compared among three groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Title
Pregabalin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Primary Outcome Measure Information:
Title
pain degree based on visual analog scale(VAS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Eligibility Criteria
Inclusion Criteria: patients candidate for PRK, 17<age<70 Exclusion Criteria: use of any systemic analgesic drugs, drug intolerance, need of systemic or topical administration of NSAIDs or eye drops for allergy and glaucoma, dry eyes, pregnancy, breast feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amir faramarzi, MD
Phone
+982122585952
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
ZIP/Postal Code
166666
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Faramarzi, MD
Email
labbafi@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

The Effect of Gabapentin (Neurentin) and Pregabalin (Lyrica) in Pain Reduction After Photorefractive Keratectomy

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