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Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01009021
Enrollment
30
Registered
2009-11-06
Start date
2008-03-31
Completion date
2009-03-31
Last updated
2009-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

pain, retinal photocoagulation, potassium diclofenac

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.

Interventions

DRUGpotassium diclofenac

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

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Pain recorded using a Visual Analog Scale15 minutes after the procedure

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026