A study to demonstrate the effect of topical anesthetics Lidocaine and Prilocaine cream in subject undergoing cannulation for blood investigation.

A Randomized, Double Blind, Placebo-Controlled, 3 Way Cross-Over Study to Demonstrate the Therapeutic Non-Inferiority of Lidocaine 2.5% and Prilocaine 2.5% Cream (Test Product) to Reference Product EMLA 5% (Lidocaine 25 mg/g and Prilocaine 25 mg/g) Cream in Male and Female Subjects Undergoing Forearm Cannulation. - Not applicable

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058420

Enrollment

Registered

2023-10-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Lidocaine 2.5% and Prilocaine 2.5% Cream: A thick layer of 2 g cream which is approximately half of 5 g tube should be applied to the skin without rubbing, under an occlusive dressing t

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female between 18 to 65 years of age (both inclusive). 2. Subject who found peripheral venous cannulation painful (define as a pain recording of 25mm or greater on a 100 mm VAS for pain) without local anaesthetic. 3. The subject is willing to complete all the study procedures including study-related tasks, and comply with the study requirements. 4. Subject with the ability to read and provide written, personally signed, and dated informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1.Subject with mental illness. 2.Known allergy or sensitivity to local anesthetics or hypersensitivity to lidocaine and/or prilocaine or local anaesthetics of the amide type or to any of the excipients. 3.Damaged or inflamed skin or open wounds at the designated application site. 4.Use of analgesics during the past 24 hours. 5.Participation in any other study during last 1 month. 6.Suspected lack of compliance with any requirements of the study. 7.Any relevant abnormalities in the routine laboratory tests. 8.Smokers 9.Agitated or uncooperative subject. 10.Uncommunicative/deaf/mute subject. 11.Subject on hypnotics, or chronic pain relief medications. 12.Subject with hepatic impairment. 13.Subjects with atopic dermatitis 14.Subject who are on CYP450 3A4, 3A5 or 1A2-inducing or inhibiting drugs (erythromycin, ciprofloxacin, amiodarone etc.) or pharmacotherapeutic agents that affect hepatic blood flow (metoprolol) since both may affect the metabolism of lidocaine. 15.Subjects with defective glucose-6-phosphate dehydrogenase, hereditary or idiopathic methaemoglobinaemia. 16.Subjects treated with anti-arrhythmics of class III (e.g., amiodarone), methaemoglobin-inducing medicinal products (e.g. sulphonamides, nitrofurantoin, phenytoin, phenobarbital), medicinal products that reduce the clearance of lidocaine (e.g., cimetidine or betablockers). 17.Subjects with Class I antiarrhythmic drugs (such as tocainide and mexiletine) which can have additive and potentially synergistic toxic effects. 18.Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.

Design outcomes

Primary

Measure	Time frame
Change in pain score based on VAS score from baselineTimepoint: Day 1, Day 7, Day 14	—

Secondary

Measure	Time frame
•Treatment Emergent Adverse events (TEAEs) •Assessment of local tolerability (after 5 min & 30 min after cannula removal)Timepoint: Day 1, Day 7, Day 14	—

Countries

India

Contacts

Public ContactDr Milan Satia

Ethicare Clinical Trial Service

milansatia@ethicare-cro.com9825585119

Outcome results