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Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
potassium diclofenac
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring pain, retinal photocoagulation, potassium diclofenac

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1)high-risk proliferative diabetic retinopathy in both eyes

Exclusion Criteria:

  • 1)history of prior laser treatment or vitrectomy; 2) allergy to non-steroidal anti-inflammatory drugs; 3) any condition affecting comprehension of VAS pain score test; 4) Contra-indications for diclofenac use such as pregnancy, bleeding disorders, asthma, or renal failure; 5) use of any analgesic drug for the last 24 hours.

Sites / Locations

  • Ribeirão Preto School of Medicine Clinics Hospital - USP

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Placebo first (scheme 2)

Diclofenac first (scheme 1)

Arm Description

scheme 2 patients (n=15) received a brown-coated tablet of saccharine (placebo) 45 minutes before the first PRP episode [placebo treatment episode (PTE)] at baseline to the right eye and two weeks after received one 50 mg tablet of potassium diclofenac 45 minutes before the second PRP episode [diclofenac treatment episode (DTE)] to the left eye

scheme 1 patients (n=15) received one 50 mg tablet of potassium diclofenac 45 minutes before the first PRP episode [diclofenac treatment episode (DTE)] at baseline to the right eye and two weeks after received an identical brown-coated tablet of saccharine (placebo) 45 minutes before the second PRP episode [placebo treatment episode (PTE)] to the left eye

Outcomes

Primary Outcome Measures

Pain recorded using a Visual Analog Scale

Secondary Outcome Measures

Full Information

First Posted
November 5, 2009
Last Updated
November 5, 2009
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01009021
Brief Title
Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy
Official Title
Analgesic Effectiveness of Potassium Diclofenac for Retinal Photocoagulation in Patients With High-risk Proliferative Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to evaluate the analgesic effect of oral potassium diclofenac in patients with proliferative diabetic retinopathy submitted to retinal photocoagulation. Two groups of patients were followed and the effect of the treatment (diclofenac plus laser) was compared to placebo (placebo plus laser). Pain associated with treatment was recorded using a Visual Analog Scale 15 minutes after the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
pain, retinal photocoagulation, potassium diclofenac

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo first (scheme 2)
Arm Type
Other
Arm Description
scheme 2 patients (n=15) received a brown-coated tablet of saccharine (placebo) 45 minutes before the first PRP episode [placebo treatment episode (PTE)] at baseline to the right eye and two weeks after received one 50 mg tablet of potassium diclofenac 45 minutes before the second PRP episode [diclofenac treatment episode (DTE)] to the left eye
Arm Title
Diclofenac first (scheme 1)
Arm Type
Other
Arm Description
scheme 1 patients (n=15) received one 50 mg tablet of potassium diclofenac 45 minutes before the first PRP episode [diclofenac treatment episode (DTE)] at baseline to the right eye and two weeks after received an identical brown-coated tablet of saccharine (placebo) 45 minutes before the second PRP episode [placebo treatment episode (PTE)] to the left eye
Intervention Type
Drug
Intervention Name(s)
potassium diclofenac
Other Intervention Name(s)
Cataflan
Intervention Description
potassium diclofenac 50 mg, one tablet 45 minutes before laser treatment
Primary Outcome Measure Information:
Title
Pain recorded using a Visual Analog Scale
Time Frame
15 minutes after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1)high-risk proliferative diabetic retinopathy in both eyes Exclusion Criteria: 1)history of prior laser treatment or vitrectomy; 2) allergy to non-steroidal anti-inflammatory drugs; 3) any condition affecting comprehension of VAS pain score test; 4) Contra-indications for diclofenac use such as pregnancy, bleeding disorders, asthma, or renal failure; 5) use of any analgesic drug for the last 24 hours.
Facility Information:
Facility Name
Ribeirão Preto School of Medicine Clinics Hospital - USP
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
23812521
Citation
Lucena CR, Ramos Filho JA, Messias AM, Silva JA, Almeida FP, Scott IU, Ribeiro JA, Jorge R. Panretinal photocoagulation versus intravitreal injection retreatment pain in high-risk proliferative diabetic retinopathy. Arq Bras Oftalmol. 2013 Jan-Feb;76(1):18-20. doi: 10.1590/s0004-27492013000100006.
Results Reference
derived

Learn more about this trial

Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy

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