Efficacy of Transdermal Microneedle Patch for Topical Anesthesia Enhancement in Paediatric Thalassemia Patients

Summary

Microneedle (MN) is the 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 minutes. So far, maltose MN efficacy in enhancing the transdermal drug delivery (TDD) of topical anaesthetic agent such as Eutectic Mixture of Local Anesthetics (EMLA) and thus reducing the pain experienced by paediatric thalassemic patients requiring intravenous cannulation for regular blood transfusion has not been extensively studied. Therefore, the goals of this research are: 1) To compare the VAS score between thalassemic paediatric patients receiving EMLA before IV cannulation for blood transfusion and those receiving EMLA without microneedle application; 2) To compare the skin conductance algesimeter index between those receiving EMLA and microneedle and those receiving EMLA without microneedle application prior to intravenous (IV) cannulation for blood transfusion; 3) To evaluate the agreement between VAS score and the skin conductance algesimeter index obtained via PainMonitor™ machine.

Conditions

• Thalassemia in Children

Interventions

DEVICE

Microneedle

Maltose Microneedle Patch (Patch Size: 1 cm x 1 cm, 36 microneedles per patch, microneedle's height, base width and tip radius are 400 μm, 100 μm and 3 μm, respectively) will be firmly applied for 5 seconds on the 1 cm x 1 cm site for IV cannulation on the dorsal surface of the hand for blood transfusion, prior to EMLA cream application.

DRUG

1 Finger Tip Unit (FTU) EMLA Cream (30-minute application time)

1 Finger Tip Units (FTU) EMLA applied for 30 minutes on the dorsal surface of the IV cannulated hand for blood transfusion

DRUG

1 Finger Tip Unit (FTU) EMLA (15-minute application time)

1 Finger Tip Unit (FTU) EMLA applied for 15 minutes on the dorsal surface of the IV cannulated hand

DRUG

0.5 Finger Tip Unit (FTU) EMLA (30-minute application time)

0.5 Finger Tip Unit (FTU) EMLA applied for 30 minutes on the dorsal surface of the IV cannulated hand for blood transfusion

DEVICE

Sham Patch

A Polyvinyl Alcohol (PVA)-containing Polyethylene Terephthalate (PET) Sham Patch of a size of 1cm x 1cm will be applied for 5 seconds against the pre-specified 1 cm x 1 cm grid on the dorsal surface of the IV cannulated hand for blood transfusion.

Sponsors & Collaborators

• Institue of Microengineering and Nanoelectronics (IMEN), Universiti Kebangsaan Malaysia

  collaborator UNKNOWN

• Universiti Kebangsaan Malaysia Medical Molecular Biology Institute (UMBI)

  collaborator UNKNOWN

• Universiti Kebangsaan Malaysia Medical Centre

  lead OTHER

Principal Investigators

• FOOK-CHOE CHEAH, MD, MRCPCH, PhD · HOSPITAL CANSELOR TUANKU MUHRIZ, UNIVERSITI KEBANGSAAN MALAYSIA MEDICAL CENTER

• AZRUL A HAMZAN, BSc, PhD · INSTITUTE OF MICROENGINEERING AND ELECTRONICS (IMEN), UKM

• CHANG FU DEE, BSc, PhD · INSTITUTE OF MICROENGINEERING AND ELECTRONICS (IMEN), UKM

• XIN YUN CHUA, BSc · HOSPITAL CANSELOR TUANKU MUHRIZ, UKM (UNIVERSITI KEBANGSAAN MALAYSIA MEDICAL CENTRE)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

6 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-15

Primary Completion

2022-08-11

Completion

2022-08-11

Countries

• Malaysia

Study Locations