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Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01009021
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : November 6, 2009
Sponsor:
Information provided by:
University of Sao Paulo

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pain Drug: potassium diclofenac Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Analgesic Effectiveness of Potassium Diclofenac for Retinal Photocoagulation in Patients With High-risk Proliferative Diabetic Retinopathy
Study Start Date : March 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo first (scheme 2)
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
 Drug: potassium diclofenac
potassium diclofenac 50 mg, one tablet 45 minutes before laser treatment
Other Name: Cataflan
Diclofenac first (scheme 1)
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
 Drug: potassium diclofenac
potassium diclofenac 50 mg, one tablet 45 minutes before laser treatment
Other Name: Cataflan


Outcome Measures
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Primary Outcome Measures :
  1. Pain recorded using a Visual Analog Scale [ Time Frame: 15 minutes after the procedure ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009021


Locations
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Brazil
Ribeirão Preto School of Medicine Clinics Hospital - USP
Ribeirão Preto, São Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rodrigo Jorge, University of Sao Paulo Professor
ClinicalTrials.gov Identifier: NCT01009021    
Other Study ID Numbers: NSAID-PRP
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: November 6, 2009
Last Verified: November 2009
Keywords provided by University of Sao Paulo:
pain
retinal photocoagulation
potassium diclofenac
Additional relevant MeSH terms:
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Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action