Lignocaine microneedle patch versus 5% EMLA patch for numbing the skin before blood draws in adults
Transdermal Microneedle Lignocaine Delivery Versus EMLA Patch for Topical Analgesia Before Venepuncture Procedure To Adults in Clinical Setting
We will try a dissolvable maltose microneedle patch that delivers lignocaine to numb the skin before blood draws in adults having eye surgery and compare it with the standard 5% EMLA patch.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universiti Kebangsaan Malaysia Medical Centre Academic / other |
| Locations | 1 site (Kuala Lumpur, Kuala Lumpur) |
| Trial ID | NCT05694858 on ClinicalTrials.gov |
What this trial studies
This is a prospective Phase I/II clinical program comparing a lignocaine-loaded dissolvable maltose microneedle patch with a standard 5% EMLA dermal patch for topical analgesia prior to venepuncture in adults undergoing ophthalmic procedures. Phase I is an open-label, non-randomized single-group pharmacokinetic and safety evaluation of 12.5 mg lignocaine-embedded microneedle in 20 patients. Phase II is a randomized, double-blind, two-parallel-group active-controlled pharmacodynamic trial comparing analgesic effect and tolerability of the microneedle patch versus EMLA. All procedures are conducted at a single center and outcomes include safety, tolerability, systemic lignocaine exposure, and pain during venepuncture.
Who should consider this trial
Good fit: Adults aged 18 or older who require venepuncture before cataract, glaucoma, or other routine ophthalmic procedures and who do not have hepatic or renal impairment and meet safety criteria are the intended participants.
Not a fit: Patients with known allergy to lignocaine or to patch materials, those on interacting CYP450 drugs or with hepatic impairment, or uncooperative/uncommunicative patients are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the microneedle patch could provide faster, effective local numbing for blood draws with a single dissolvable patch and potentially fewer local or systemic side effects than topical cream.
How similar studies have performed: There are limited prior clinical data on lignocaine-loaded dissolvable maltose microneedles for venepuncture; preclinical and small human feasibility work exists but definitive efficacy data are not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kuala Lumpur, Kuala Lumpur
- Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia (Ukm Medical Centre) — Kuala Lumpur, Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Principal investigator: FOOK CHOE CHEAH, MD, PhD, MRCPCH — Faculty of Medicine, Universiti Kebangsaan Malaysia (Ukm)
- Study coordinator: MUHAMMAD IRFAN BIN ABDUL JALAL, MBChB BAO, PhD
- Email: irfan.abduljalal@ukm.edu.my
- Phone: +60172107299
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.