Lignocaine microneedle patch versus 5% EMLA patch for numbing the skin before blood draws in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.