HEAD-TO-HEAD COMPARISON OF TOLERABILITY AND ACCEPTABILITY OF SINGLE DOSE OF FOUR TOPICAL NSAIDS IN PATIENTS UNDERGOING CATARACT SURGERY: A RANDOMIZED OPEN LABEL PARALLEL GROUP STUDY
Journal Title: Journal of Evidence Based Medicine and Healthcare - Year 2015, Vol 2, Issue 31
Abstract
Ophthalmic NSAIDs are used to control pain, discomfort and inflammation associated with ocular conditions and also, following ophthalmic cataract surgeries. These drugs can cause ocular discomfort following administration which lasts for a short duration. However, there exist differences in the intensity and duration of burning sensation among the commonly used ophthalmic NSAIDs. Hence, we evaluated the tolerability and acceptability of four topical NSAIDS i.e., 0.3% nepafenac (N), 0.5% ketorolac (K), 0.4% ketorolac (KLS) and 0.09% bromfenac (B) after instilling a single drop. METHODS: This randomized, open label, parallel group study was conducted in the department of Ophthalmology in Narayana Medical College, Nellore. A total number of 80 patients participated in the study. Randomization list was computer generated in a ratio of 1:1:1:1 of N, K, K L Sand B. Each patient received one drop of the study drug either in right or left eye which was also decidedat random.Patients of either gender above21 years of age, having no ocular surface pathology and eligible for cataract surgery were included in the study. Outcome variables included ocular burning intensity on VAS (0-100 mm) at 0 min (immediately), 2 min and 6 min after administration of medications, time to complete pain relief and global medication performance rated by patient as 0 (bad), 1(fair), 2(good) or 3 (severe). RESULTS: The mean age of patients was 52.85±17.46 years. All groups were age matched, however there were more females than males (p<0.02). Randomization has led to nonsignificant allocation of eyes to treatment. The intensity of burning sensation measured on VAS at 0 min was statistically significant between the groups i.e., N vs. K=P<0.001, K vs. B=P<0.001 and K LS vs. B=P<0.05. The burning sensation reached zero at 2 min with drug B whereas in N group, it was achieved at 6 min. However, patients continued to experience significant burning sensation with K at 2 min (N vs. K=P<0.05 and K vs. B= P<0.01). No significant observation was found at 6 min between any of the medications though patients in K and K LS experienced some amount of burning sensation. Time to complete relief of discomfort was significant between the groups (N vs. K= P<0.05, K vs. B=P<0.05 and K LS vs. B= P<0.05). Majority of patients rated the drugs in the order of B>N>KLS>K on global medication performance. CONCLUSION: Bromfenac had better tolerability and acceptability as compared to other tested topical NSAIDs, which was in the order of B>N> K LS>K.
Authors and Affiliations
Chandra Sekhar G. , Rama Mohan Pathapati, Varalakshmi U. , Sarvepalli Skanda Harshita, Rajkumar Patra, Praneet Praneet, Madhavulu Madhavulu, Divyalasya T. V. S.
Keywords
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- EP ID EP229192
- DOI 10.18410/jebmh/2015/643
- Views 57
- Downloads 0
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