Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type OTHER

potassium diclofenac

Intervention Type DRUG

potassium diclofenac 50 mg, one tablet 45 minutes before laser treatment

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

Group Type OTHER

potassium diclofenac

Intervention Type DRUG

potassium diclofenac 50 mg, one tablet 45 minutes before laser treatment

Interventions

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potassium diclofenac

potassium diclofenac 50 mg, one tablet 45 minutes before laser treatment

Intervention Type DRUG

Other Intervention Names

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Cataflan

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No