Transdermal Microneedle Lignocaine Delivery Versus EMLA Patch for Topical Analgesia Before Venepuncture Procedure To Adults in Clinical Setting
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Visual Analogue Score (VAS)
研究概览
简要总结
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).
详细描述
This is a prospective, phase I/II, randomized, triple-blind (participants and care providers), two-parallel group, active controlled trial.
This study is divided into two phases:
A) Phase I: Non-randomized single-centre open-label single group clinical trial to primarily assess the safety and tolerability of lignocaine-impregnated microneedle in adult patients undergoing routine vein-puncturing related procedures (pharmacokinetic (PK) study).
B) Phase II: A randomized single centre double blind two parallel group active controlled clinical trial to assess the efficacy of lignocaine-impregnated microneedle compared to 5% EMLA dermal patch (Pharmacodynamic (PD) study).
I) Phase I Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 years old and above
- •Patients requiring venepuncture for blood investigations before ophthalmological procedures
排除标准
- •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.
研究组 & 干预措施
Lignocaine-Embedded Microneedle Patch
A biodegradable maltose microarray needle (MAN) patch loaded with 12.5 mg lignocaine will be applied on the dorsum of the participant's hand for 30 minutes. Venepuncture will be carried out after 30 minutes.
干预措施: Lignocaine-loaded maltose microneedle array patch (Combination Product)
EMLA 5% Patch
1 finger-tip unit (FTU) of EMLA containing 12.5 mg lignocaine and 12.5 mg prilocaine will be applied on the dorsum aspect of the participant's hand. This will then be covered by a Polyvinyl Alcohol (PVA)-Polyethylene Terephthalate (PET) adhesive and left in place for 30 minutes. Venepuncture will be carried out after 30 minutes.
干预措施: EMLA 5% patch (Drug)
结局指标
主要结局
Visual Analogue Score (VAS)
时间窗: The measurements will be made at 1 minute after venepuncture which will be inserted following EMLA-impregnated microneedle patch or standard EMLA patch application]
VAS score is measured in a continuous scale (range 0-100). It is obtained using a Med-05-100 VAS Pain Scale ruler (Schlenker Enterprises Ltd, Lombard, USA) with 0-100 mm slider. It is measured based on the pain experienced on the venepunctured hand. Higher VAS score indicates greater intensity or degree of pain whilst lower VAS score indicates lesser pain intensity.
Skin Conductance Algesimeter Index
时间窗: The measurements will be made at 1 minute after venepuncture which will be inserted following EMLA-impregnated microneedle patch or standard EMLA patch application]
The skin conductance peaks per second, measured in microSiemens per second (μS/s), is obtained using PainMonitor™ (Med-Storm Innovation AS, Oslo, Norway) device on the hypothenar eminence of the opposite hand not receiving venepuncture. Higher skin conductance algesimeter index indicates greater pain intensity and lower values indicate lesser pain intensity.
次要结局
未报告次要终点