Health Condition 1: null- In patients scheduled for diagnostic Laryngoscopy and/or punch biopsy of upper aero-digestive tract.
Conditions
Interventions
Intervention1: Lidocaine Lozenges- 100 mg or 200 mg: Lidocaine Lozenges- 100 mg or 200 mg unit is to be taken 15-20 mins prior to procedure
Control Intervention1: Lidocaine spray equivalent to 100 mg
Sponsors
Troikaa Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either sex aged 18-80 years. 2.Patients undergoing diagnostic laryngoscopy and/or punch biopsy of upper aero-digestive tract. 3.American Society of Anesthesiologist (ASA) Physical status I and II of patients.
Exclusion criteria
Exclusion criteria: 1.History of hypersensitivity to amide type lidocaine anesthetics or any component of the formulation 2.Patients with medical history of respiratory disease such as asthma, bronchitis or chronic obstructive pulmonary disease. 3.Use of another topical product at application site 4.Expecting unusual surgical difficulty 5.Unwilling patients. 6.Emergency surgery/ surgery needing hospitalization 7.Clinically significant impairment of hepatic/renal/cardiac functions 8.Any condition that, in the opinion of the investigator, does not justify the patients inclusion in the study 9.Pregnant women and lactating mothers 10.Women of child bearing age not practicing contraception 11.Participation in a clinical study involving an investigational product within past 30 days 12.Patient known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency, or psychotic state).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ease of application of anaesthetic agent.Timepoint: On the day of diagnostic laryngoscopy and/or punch biopsy of upper aero-digestive tract. After the procedure is completed;Ease of application of anaesthetic agent.Timepoint: On the day of diagnostic laryngoscopy and/or punch biopsy of upper aero-digestive tract. After the procedure is completed;Ease of application of anaesthetic agent.Timepoint: On the day of diagnostic laryngoscopy and/or punch biopsy of upper aero-digestive tract. After the procedure is completed | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of Topical analgesia as determined by ease of procedure Physician Global assessment side effectsTimepoint: After the completion of procedure | — |
Countries
India
Contacts
Public ContactDr Sanjay Maroo
Troikaa Pharmaceuticals Limited
Outcome results
None listed