NCT02837770

Effect of Topical and Oral Diclofenac on Pain Related to Intravitreal Injections

Analgesic Effect of Topical and Oral Diclofenac on Pain Related to Intravitreal Injections, a Randomized, Triple-arm, Double-blind, Placebo-controlled Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: University Hospital of Patras · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The analgestic efffect of Diclofenac Sodium 0.1% Eye Drops and a combination of Diclofenac Sodium 0.1% Eye Drops and oral Diclofenac Sodium sustained-release 75mg tablets on pain related to intravitreal injections will be evalutated. Pain perception will be assessed by the Short Form of the McGill Pain Questionnaire.

Detailed description

Intravitreal injection (IVI) is a preferred route of administration of drugs in the posterior segment of the eye. Intravitreal injection of anti-VEGFs constitutes the mainstay for the treatment of various retinal diseases such as AMD, RVO, DME etc. The procedure of the IVI is, however, associated with a level of discomfort for the patient. Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit the activity of cyclooxygenase-1 and cyclooxygenase-2, and thereby, the synthesis of prostaglandins and thromboxanes. Cyclooxygenase-2 inhibition leads to the anti-inflammatory, analgesic and antipyretic effects of NSAIDs. Ophthalmic NSAIDs constitute an established and effective treatment option for the management of inflammation and pain associated with cataract surgery and of pain associated with corneal refractive surgery, for inhibition of intraoperative miosis and for the treatment of seasonal allergic conjunctivitis. The primary goal of this study is to assess the analgesic effect of DIclofenac 0.1% Eye Drops a topical NSAID, as well as a combination of Diclofenac 0.1% Eye Drops and oral Diclofenac Sodium sustained-release (SR) 75mg tablets on pain related to intravitreal injections immediately after and up to six hours post-IVI. A number of patients scheduled to undergo IVIs of anti-VEGFs will be randomized and divided in three groups. All patients must have already undergone at least one IVI. In patients receiving IVIs in both eyes only one eye will be included in the study. The patients of the first group will receive placebo pill 4 hours before the IVI and Diclofenac 0.1 % Eye Drops 45 minutes prior to the injection. The patients of the second group will recieve oral Diclofenac Sodium SR 75mg/tb 4 hours prior to the injection and Diclofenac 0.1% Eye Drops 45 minutes prior to the injection. The patients of the third group will receive placebo pill 4 hours and Artificial Tears 45 minutes prior to the injection. Patients will be required to complete the greek version of the short form McGill Pain Questionnaire (SF-MPQ) comprising of the Visual Analogue Scale, the main component of the SF-MPQ and the Present Pain Intensity Scale immediately after the injection and 6 hours post-IVI.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Diclofenac Eye Drops	One drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.
DRUG	Pacebo pill	Pacebo pill will be administered 4 hours before the IVI.
DRUG	Oral Diclofenac	One Diclofenac Sodium sustained-release 75mg tablet administered per os 4 hours prior to the IVI.
DRUG	Diclofenac Eye Drops	One drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.
DRUG	Pacebo pill	Pacebo pill will be administered 4 hours before the IVI.
DRUG	Artificial Tears	One drop Artificial Tears will be instilled 45' prior to the IVI.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2016-07-20
• Last updated: 2017-01-10

Locations

1 site across 1 country: Greece