To determine the efficacy, safety and ease of use of Lidocaine Lozenges as compared to lidocaine spray in patients undergoing diagnostic laryngoscopy and/or punch biopsy of upper aero-digestive tract.
- Conditions
- Health Condition 1: null- In patients scheduled for diagnostic Laryngoscopy and/or punch biopsy of upper aero-digestive tract.
- Registration Number
- CTRI/2011/091/000155
- Lead Sponsor
- Troikaa Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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.
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).
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method