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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllUniversiti Kebangsaan Malaysia Medical Centre
NCT05694858 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Lignocaine-loaded maltose microneedle array patch
  • EMLA 5% patch
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Where

1 site
Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia (Ukm Medical Centre)
Kuala Lumpur, Malaysia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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