Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy

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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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ribeirão Preto School of Medicine Clinics Hospital - USP

Ribeirão Preto, São Paulo, 14049-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

potassium diclofenac

Drug

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

Other names: Cataflan

Primary outcomes

Pain recorded using a Visual Analog Scale

Time frame: 15 minutes after the procedure

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Analgesic Effectiveness of Potassium Diclofenac for Retinal Photocoagulation in Patients With High-risk Proliferative Diabetic Retinopathy

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Nov 6, 2009
Registry last updated: Nov 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed