Pain Clinical Trial
Official title:
Analgesic Effect of Topical and Oral Diclofenac on Pain Related to Intravitreal Injections, a Randomized, Triple-arm, Double-blind, Placebo-controlled Study.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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