Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: potassium diclofenac

• Registration Number: NCT01009021
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-11
• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-05
• Last Update Submitted: 2009-11-05
• Study First Posted: 2009-11-06
• Last Update Posted: 2009-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diclofenac first (scheme 1)	potassium diclofenac	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
Placebo first (scheme 2)	potassium diclofenac	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

Primary Outcome Measures

Name	Time	Method
Pain recorded using a Visual Analog Scale	15 minutes after the procedure

Trial Locations

Locations (1)

Ribeirão Preto School of Medicine Clinics Hospital - USP; 🇧🇷 Ribeirão Preto, São Paulo, Brazil