A prospective, randomized, active controlled, double blind, comparative, parallel arm study to evaluate the efficacy, and safety of topical eutectic mixture of Lidnocaine + Prilocaine in patients requiring dermal anaesthesia.

Themis Medicare Limited0 个研究点目标入组 240 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•Inclusion Criteria
•1. Patients of either sex in the age group between 18 to 70 years.
•2.Patients presenting to the surgery / general/ medicine OPD requiring dermal anaesthesia to prevent pain for superficial surgical procedures such as needle insertion, intravenous cannulation, blood sampling and superficial surgery on skin (removal of molluscum contagiosum , split-skin grafting, electrolysis; laser treatment.)
•3. Subjects who provide a written informed consent to abide by the study requirements.

•Exclusion Criteria
•1. Patients requiring application of the local anaesthetic drugs on broken skin or on mucous membranes or near the eye region.
•2. Patients who have received (within 24 hours) or require local / general anaesthesia for any other concomitant indication.
•3. Patients with a known history of sensitivity to local anesthetics of the amide type (for eg: lidocaine, prilocaine, mepivicaine, bupivicaine, etidocaine).
•4. Patients with a known hypersensitivity to any component of eutectic mixture or suffering from atopic dermatitis.
•5. Patients requiring an occlusive dressing post procedure.
•6.Patients with congenital or idiopathic methemoglobinemia or presenting with glucose-6-phosphate dehydrogenase deficiencies
•7. Patients who are receiving concomitant treatment with methemoglobin-inducing drugs (for eg:sulfonamides, acetaminophen, benzocaine, chloroquine, dapsone, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, phenobarbital, phenytoin, primaquine, and quinine).
•8. Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
•9. Pregnant and lactating females.
•10. Simultaneous participation in another clinical study

发起方