RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Transdermal Microneedle Lignocaine Delivery Versus EMLA Patch for Topical Analgesia Before Venepuncture Procedure To Adults in Clinical Setting

About This Trial

Microneedle (MN) is a mimic of a hypodermic needle, composed of hundreds of micron-sized, out-of-plane protrusions, typically arranged in arrays on a patch that can be applied onto the skin. MN can be fabricated from a variety of materials, preferably biocompatible polymers. Maltose, a natural carbohydrate, is a safe and biocompatible product that can be fabricated into MNs that are biodegradable and soluble within several minutes. Besides, local anaesthetic agents such as lignocaine can be impregnated within the MN matrix, facilitating its transdermal delivery more efficiently which results in enhanced efficacy. So far, maltose MN efficacy in enhancing the transdermal drug delivery (TDD) of lignocaine and thus reducing the pain experienced by healthy patients requiring venepuncture prior to routine eye surgeries (phacoemulsification, trabeculectomy etc) has not been extensively studied. Hence, the objectives of this research are: 1) To evaluate the safety profile of lignocaine-embedded microneedle patch as a means of pain reduction in adult patients requiring routine vein-puncturing procedures; 2) To assess the pharmacokinetic (PK) parameters of lignocaine in the systemic circulation when the transdermal lignocaine delivery is enhanced through microneedle usage; 3) To compare the efficacy of lignocaine-embedded microneedle patch with standard 5% Eutectic Mixture of Local Anesthetics (EMLA) dermal patch for pain reduction during venepuncture procedure based on mean changes in VAS scores and skin algesimeter index (pharmacodynamic (PD) study).

Who May Be Eligible (Plain English)

Who May Qualify: - Patients aged 18 years old and above - Patients requiring venepuncture for blood investigations before ophthalmological procedures Who Should NOT Join This Trial: - Patient with a previous history of sensitization or allergy to lignocaine. - Patient with a previous history of allergy to materials used in the study i.e., plaster, electrodes, maltose, Polyvinyl Alcohol (PVA), and Polyethylene Terephthalate (PET) - Patient exposed to analgesic usage within 24 hours prior to the procedure - Generalized skin disorder/ rash - Agitated/ fretful / uncooperative patient - Uncommunicative/deaf/mute patients - Patients on hypnotics, or chronic pain relief medications - Patients with psychiatric conditions - Patients with hepatic impairment - Patients 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 lignocaine - Failed first/single attempt at venepuncture after the application of the LEMAP or PET patch for control arm. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Patients aged 18 years old and above * Patients requiring venepuncture for blood investigations before ophthalmological procedures Exclusion Criteria: * Patient with a previous history of sensitization or allergy to lignocaine. * Patient with a previous history of allergy to materials used in the study i.e., plaster, electrodes, maltose, Polyvinyl Alcohol (PVA), and Polyethylene Terephthalate (PET) * Patient exposed to analgesic usage within 24 hours prior to the procedure * Generalized skin disorder/ rash * Agitated/ fretful / uncooperative patient * Uncommunicative/deaf/mute patients * Patients on hypnotics, or chronic pain relief medications * Patients with psychiatric conditions * Patients with hepatic impairment * Patients 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 lignocaine * Failed first/single attempt at venepuncture after the application of the LEMAP or PET patch for control arm.

Treatments Being Tested

COMBINATION_PRODUCT

Lignocaine-loaded maltose microneedle array patch

A biodegradable maltose microneedle array patch containing 12.5 mg lignocaine that will be applied on the participant's dorsal aspect of the hand for 30 minutes prior to venepuncture.

DRUG

EMLA 5% patch

EMLA 5% cream applied on the dorsum of the participant's hand which will be subsequently covered with PVA-PET adhesive for 30 minutes prior to venepuncture

Locations (1)

Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia (Ukm Medical Centre)

Kuala Lumpur, Kuala Lumpur, Malaysia