Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation

Overview

The study wants to show if the medication etoricoxib 120 mg have reduces the patients pain during the laser photocoagulation, for diabetic retinopathy.

Full Title of Study: “Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)

Detailed Description

To do so we compare two group of patients, randomized 1:1, one use the medication(etoricoxib) and other use placebo and they quantify the pain using the Pain visual analogue scale

Interventions

  • Drug: placebo (Control Group)
    • Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation
  • Drug: Etoricoxib (Treatment Group)
    • Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation

Arms, Groups and Cohorts

  • Placebo Comparator: Control Group
    • Patients who received placebo
  • Active Comparator: Treatment Group
    • Patients who received etoricoxib 120 mg

Clinical Trial Outcome Measures

Primary Measures

  • The group taking the etoricoxib feel less pain then the group taking placebo
    • Time Frame: After each laser session

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with diabetic retinopathy that needs laser photocoagulation for the first time Exclusion Criteria:

  • Younger than 17 – Signs and symptoms of liver dysfunction or abnormal liver function tests – Gastrointestinal diseases – Pregnant women – Edema – Pre-existing cardiac insufficiency

Gender Eligibility: All

Minimum Age: 17 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Overall Official(s)
    • Vinicius P Nascimento, MD, Principal Investigator, Clinica Oftalmologica do Hospital das Clinicas da Universidade de São Paulo

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