Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy

Study Overview
=================
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.

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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: potassium diclofenac


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Placebo first (scheme 2)<br>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<br>* potassium diclofenac 50 mg, one tablet 45 minutes before laser treatment<br>* Other names: Cataflan;|
| Other: Diclofenac first (scheme 1)<br>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<br>* potassium diclofenac 50 mg, one tablet 45 minutes before laser treatment<br>* Other names: Cataflan;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain recorded using a Visual Analog Scale |  | 15 minutes after the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, retinal photocoagulation, potassium diclofenac