Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01009021
• Other study ID #: NSAID-PRP
• Status: Completed
• Phase: N/A
• First received: November 5, 2009
• Last updated: November 5, 2009
• Start date: March 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Pain

Intervention

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

Locations

Country	Name	City	State
Brazil	Ribeirão Preto School of Medicine Clinics Hospital - USP	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain recorded using a Visual Analog Scale		15 minutes after the procedure	No