Health Condition 1: null- Dermal Anaesthesia
Conditions
Interventions
Intervention1: Lidocaine + Prilocaine: 7.5 mg
2.5 mg as metered dose spray
Control Intervention1: Lidocaine Spray 10 %: Each actuation contains 10 mg of Lidocaine
Sponsors
Themis Medicare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of the topical eutectic mixture of Lidocaine + Prilocaine in patients requiring dermal anaesthesia for minor surgical procedures.Timepoint: 60 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of the topical eutectic mixture of Lidocaine + Prilocaine in patients requiring dermal anaesthesiaTimepoint: 60 minutes | — |
Countries
India
Contacts
Public ContactDr Sumedh M Gaikwad
Outcome results
None listed