Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy

University of Sao Paulo

Status: Completed

Conditions: Pain

Treatments: Drug: potassium diclofenac

Study type: Interventional

Funder types: Other

Identifiers

NCT01009021

NSAID-PRP

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Placebo first (scheme 2)

Other group

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

Treatment:

Drug: potassium diclofenac

Diclofenac first (scheme 1)

Other group

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

Treatment:

Drug: potassium diclofenac