Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy

NCT01009021 | Completed

• 1 other identifier: NSAID-PRP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

pain; retinal photocoagulation; potassium diclofenac

Outcome Measures

Primary Outcomes (1)

• Pain recorded using a Visual Analog Scale

  15 minutes after the procedure

Study Arms (2)

Placebo first (scheme 2)

OTHER

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

Drug: potassium diclofenac

Diclofenac first (scheme 1)

OTHER

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

Drug: potassium diclofenac

Interventions

potassium diclofenac DRUG

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

Also known as: Cataflan

Diclofenac first (scheme 1); Placebo first (scheme 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• )high-risk proliferative diabetic retinopathy in both eyes

You may not qualify if:

• )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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Ribeirão Preto School of Medicine Clinics Hospital - USP

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (1)

• Lucena CR, Ramos Filho JA, Messias AM, Silva JA, Almeida FP, Scott IU, Ribeiro JA, Jorge R. Panretinal photocoagulation versus intravitreal injection retreatment pain in high-risk proliferative diabetic retinopathy. Arq Bras Oftalmol. 2013 Jan-Feb;76(1):18-20. doi: 10.1590/s0004-27492013000100006.

  PMID: 23812521 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 6, 2009
• Study Start: March 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 6, 2009

Record last verified: 2009-11

Locations

BR (1)