Trial intelligence / Profile preview

Lignocaine Microneedle vs EMLA for Venepuncture Pain

NCT05694858Phase 2

Key facts

Status
Recruiting
Start
Feb 2025
Primary completion
Dec 2026
Countries
1
Sponsor
Hospital Canselor Tuanku Muhriz
Modality
Small Molecules
Conditions
procedural pain
01

Overview

Phase 2, randomised, triple-blind trial of lidocaine in procedural pain (2 arms), sponsored by Hospital Canselor Tuanku Muhriz. Primary endpoints: Visual Analogue Scale Pain Score and Skin Conductance Algesimeter Index. Started Feb 2025; status: recruiting.

02

Design

2 arms
Study design
RandomizedTriple-blind
  • Lignocaine Microneedle

    12.5mg lignocaine-embedded microneedle patch

  • EMLA Patch

    Standard 5% EMLA patch (12.5mg lignocaine + 12.5mg prilocaine)

03

Who it enrols

Adult patients (18+) requiring venepuncture before ophthalmological procedures. Excludes patients with allergy to lignocaine/materials, recent analgesic use (<24h), hepatic impairment, psychiatric conditions, or use of CYP450 inducers/inhibitors.

04

Endpoints

Primary

  • Visual Analogue Scale Pain Score

  • Skin Conductance Algesimeter Index

Secondary

  • Area Under the Curve

  • Maximum Plasma Concentration

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