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      Pain Following the Use of Anesthesia Formulation Among Individuals Undergoing Cataract Surgery: A Randomized Controlled Trial

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          Abstract

          Purpose

          To assess the pain intensity of two intracameral anesthetic solutions in patients undergoing cataract surgery and evaluate the factors influencing the patients’ postoperative activities.

          Methods

          Sixty-two patients undergoing cataract surgery were randomized to receive the study drug – a manufactured solution of 0.02% tropicamide/0.31% phenylephrine/1% lidocaine (Mydrane) or a traditional anesthetic formulation - solution of 1% lidocaine/0.025% adrenaline as an intraocular anesthetic. The pain intensity was assessed by Visual Analog Scale for Pain (VAS Pain) and Brief Pain Inventory-short form (BPI) on the next day after the surgery.

          Results

          The mean pain score measured preoperatively with VAS Pain was 0.34 in Mydrane group and 0.09 in the reference group ( p = 0.51). There were no statistically significant differences between the two anesthetic methods with respect to pain intensity during the surgery ( p = 0.94) and the influence of pain during the last 24 h on activity ( p = 0.79), mood ( p = 0.31), social contacts ( p = 0.29), sleep ( p = 0.5) and the joy of life ( p = 0.39). Additionally, there was no statistically significant influence of age, sex, lateralization, co-existing ophthalmological diseases ( p = 0.98) and post-operative complications ( p = 0.4) on the experienced pain measured during the surgery and in the last 24 h.

          Conclusions

          New commercially available intraocular anesthetic solution (Mydrane™) seems to be as effective as off-label traditional anesthetic formulation, in reducing the pain experienced during cataract surgery under topical anesthesia.

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          Most cited references28

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          Graphic representation of pain.

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            Topical Ocular Delivery of NSAIDs

            In ocular tissue, arachidonic acid is metabolized by cyclooxygenase to prostaglandins which are the most important lipid derived mediators of inflammation. Presently nonsteroidal anti-inflammatory drugs (NSAIDs) which are cyclooxygenase (COX) inhibitors are being used for the treatment of inflammatory disorders. NSAIDs used in ophthalmology, topically, are salicylic-, indole acetic-, aryl acetic-, aryl propionic- and enolic acid derivatives. NSAIDs are weak acids with pKa mostly between 3.5 and 4.5, and are poorly soluble in water. Aqueous ophthalmic solutions of NSAIDs have been made using sodium, potassium, tromethamine and lysine salts or complexing with cyclodextrins/solubilizer. Ocular penetration of NSAID demands an acidic ophthalmic solution where cyclodextrin could prevent precipitation of drug and minimize its ocular irritation potential. The incompatibility of NSAID with benzalkonium chloride is avoided by using polysorbate 80, cyclodextrins or tromethamine. Lysine salts and α-tocopheryl polyethylene glycol succinate disrupt corneal integrity, and their use requires caution. Thus a nonirritating ophthalmic solution of NSAID could be formulated by dissolving an appropriate water-soluble salt, in the presence of cyclodextrin or tromethamine (if needed) in mildly acidified purified water (if stability permits) with or without benzalkonium chloride and polyvinyl alcohol. Amide prodrugs met with mixed success due to incomplete intraocular hydrolysis. Suspension and ocular inserts appear irritating to the inflamed eye. Oil drop may be a suitable option for insoluble drugs and ointment may be used for sustained effect. Recent studies showed that the use of colloidal nanoparticle formulations and the potent COX 2 inhibitor bromfenac may enhance NSAID efficacy in eye preparations.
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              A prospective study on postoperative pain after cataract surgery

              Purpose To evaluate postoperative pain and early recovery in cataract patients. Patients and methods A total of 201 patients who underwent elective first eye cataract extraction surgery were enrolled, and 196 were included in the final analysis. The study design was a single-center, prospective, follow-up study in a tertiary hospital in eastern Finland. Postoperative pain was evaluated with the Brief Pain Inventory at four time points: at baseline, and at 24 hours, 1 week, and 6 weeks postsurgery. Results Postoperative pain was relatively common during the first hours after surgery, as it was reported by 67 (34%) patients. After hospital discharge, the prevalence decreased; at 24 hours, 1 week, and 6 weeks, 18 (10%), 15 (9%) and 12 (7%) patients reported having ocular pain, respectively. Most patients with eye pain reported significant pain, with a score of ≥4 on a pain scale of 0–10, but few had taken analgesics for eye pain. Those who had used analgesics rated the analgesic efficacy of paracetamol and ibuprofen as good or excellent. Other ocular irritation symptoms were common after surgery; as a new postoperative symptom, foreign-body sensation was reported by 40 patients (22%), light sensitivity by 29 (16%), burning by 15 (8%), and itching by 15 (8%). Conclusion Moderate or severe postoperative pain was relatively common after cataract surgery. Thus, all patients undergoing cataract surgery should be provided appropriate counseling on pain and pain management after surgery.
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                Author and article information

                Contributors
                Journal
                Front Pharmacol
                Front Pharmacol
                Front. Pharmacol.
                Frontiers in Pharmacology
                Frontiers Media S.A.
                1663-9812
                16 April 2020
                2020
                : 11
                : 440
                Affiliations
                [1] 1Department of General Ophthalmology, Medical University of Lublin , Lublin, Poland
                [2] 2Faculty of Medicine, Collegium Medicum, Cardinal Stefan Wyszynski University , Warsaw, Poland
                [3] 3Department of Mathematics and Medical Biostatistics, Medical University of Lublin , Lublin, Poland
                [4] 4Department of Ophthalmology, School of Medicine, University of Catania , Catania, Italy
                [5] 5Department of Biomedical and Biotechnological Sciences, School of Medicine, University of Catania , Catania, Italy
                [6] 6Department of General Surgery and Surgical Specialties, Division of Anesthesiology, Azienda Ospedaliero-Universitaria Policlinico , Catania, Italy
                [7] 7Department “GF. Ingrassia”, Section of Neurosciences, University of Catania , Catania, Italy
                Author notes

                Edited by: Joseph O. Fadare, Ekiti State University, Nigeria

                Reviewed by: Amit D. Raval, Merck, United States; Domenico Criscuolo, Italian Society of Pharmaceutical Medicine, Italy

                *Correspondence: Mario D. Toro, toro.mario@ 123456email.it

                This article was submitted to Pharmaceutical Medicine and Outcomes Research, a section of the journal Frontiers in Pharmacology

                Article
                10.3389/fphar.2020.00440
                7176993
                a801e2a0-4abb-4319-a56e-fc7d7ce17649
                Copyright © 2020 Toro, Nowakowska, Brzozowska, Reibaldi, Avitabile, Bucolo, Murabito, Chisari, Nowomiejska and Rejdak

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 24 November 2019
                : 20 March 2020
                Page count
                Figures: 2, Tables: 6, Equations: 0, References: 29, Pages: 9, Words: 5005
                Categories
                Pharmacology
                Original Research

                Pharmacology & Pharmaceutical medicine
                cataract surgery,pain,ophthalmologic anesthesia,intraocular anesthesia,tropicamide,phenylephrine,lidocaine

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