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

NCT05078463 | Completed Phase 2 DMC

• 2 other identifiers: UKM PPI/111/8/JEP-2021-578PRGS/2/2020/TK05/UKM/01/1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Microneedle; Maltose Microneedle; Thalassemia in Children; Paediatric Thalassemia; Transdermal microneedle patch; EMLA; Intravenous cannulation; Blood transfusion; Intravenous line insertion

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Score (VAS)

  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 IV cannulated hand for blood transfusion. Higher VAS score indicates greater intensity or degree of pain whilst lower VAS score indicates lesser pain intensity.

  The measurements will be made at 1 minute after IV cannulation which will be inserted following EMLA (with or without microneedle) application

• Skin Conductance Algesimeter Index

  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 blood transfusion. Higher skin conductance algesimeter index indicates greater pain intensity and lower values indicate lesser pain intensity.

  The measurements will be made at 1 minute after IV cannulation which will be inserted following EMLA (with our without microneedle) application

Study Arms (4)

Intervention A: Microneedle with 1 Finger Tip Unit (FTU) EMLA for 30 minutes

EXPERIMENTAL

A Maltose Microneedle array patch (size: 1 cm x 1 cm) containing 36 microneedles (the height, base width and tip radius of each microneedle are 400 μm, 100 μm and 3 μm, respectively) with 1 mm needle gap in between will be firmly applied for 5 seconds against the pre-specified 1 cm x 1 cm grid (which will be the ideal site for intravenous cannulation for blood transfusion) on the dorsal surface of the hand. 1 Finger Tip Unit (FTU) of EMLA cream (containing an equal amount (25 mg) of lidocaine 2.5% and prilocaine 2.5%) (approximately 0.68g/cm2) will then be topically applied for 30 minutes on the same site of microneedle application. Intravenous cannulation will subsequently be carried out.

Device: Microneedle; Drug: 1 Finger Tip Unit (FTU) EMLA Cream (30-minute application time)

Intervention B: Microneedle with 0.5 Finger Tip Unit (FTU) EMLA for 30 minutes

EXPERIMENTAL

A Maltose Microneedle array patch (size: 1 cm x 1 cm) containing 36 microneedles (the height, base width and tip radius of each microneedle are 400 μm, 100 μm and 3 μm, respectively) with 1 mm needle gap in between will be firmly applied for 5 seconds against the pre-specified 1 cm x 1 cm grid (which will be the ideal site for intravenous cannulation for blood transfusion) on the dorsal surface of the hand. 0.5 Finger Tip Unit (FTU) of EMLA cream containing an equal amount (25 mg) of lidocaine 2.5% and prilocaine 2.5% (dose: approximately 0.369 g/cm2) will then be topically applied for 30 minutes on the same site of microneedle application. Intravenous cannulation will subsequently be carried out.

Device: Microneedle; Drug: 0.5 Finger Tip Unit (FTU) EMLA (30-minute application time)

Intervention C: Microneedle with 1 Finger Tip Units (FTUs) EMLA for 15 minutes

EXPERIMENTAL

A Maltose Microneedle array patch (size: 1 cm x 1 cm) containing 36 microneedles (the height, base width and tip radius of each microneedle are 400 μm, 100 μm and 3 μm, respectively) with1 mm needle gap in between will be firmly applied for 5 seconds against the pre-specified 1 cm x 1 cm grid (which will be the ideal site for intravenous cannulation for blood transfusion) on the dorsal surface of the hand. One (1) Finger Tip Unit (FTU) of EMLA cream (containing an equal amount (25 mg) of lidocaine 2.5% and prilocaine 2.5%) (approximately 0.68g/cm2) will then be topically applied for 15 minutes on the same site of microneedle application. Intravenous cannulation will subsequently be carried out.

Device: Microneedle; Drug: 1 Finger Tip Unit (FTU) EMLA (15-minute application time)

Intervention D: 1 Finger Tip Unit (FTUs) EMLA only and PVA-containing PET Sham Patch

SHAM COMPARATOR

A Polyvinyl Alcohol (PVA)-containing Polyethylene Terephthalate (PET) Sham Patch of 1 cm x 1cm size will be applied for 5 seconds against the pre-specified 1 cm x 1 cm grid (which will be the ideal site for intravenous cannulation for blood transfusion) on the dorsal surface of the hand. One (1) Finger Tip Unit (FTU) of EMLA cream (containing an equal amount (25 mg) of lidocaine 2.5% and prilocaine 2.5%) (approximately 0.68g/cm2) will then be topically applied for 30 minutes on the same site of microneedle application. Intravenous cannulation will subsequently be carried out.

Drug: 1 Finger Tip Unit (FTU) EMLA Cream (30-minute application time); Device: Sham Patch

Interventions

Microneedle DEVICE

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.

Also known as: Maltose Microneedle Array Patch, Maltose Microneedle Patch

Intervention A: Microneedle with 1 Finger Tip Unit (FTU) EMLA for 30 minutes; Intervention B: Microneedle with 0.5 Finger Tip Unit (FTU) EMLA for 30 minutes; Intervention C: Microneedle with 1 Finger Tip Units (FTUs) EMLA for 15 minutes

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

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

Also known as: EMLA topical cream

Intervention A: Microneedle with 1 Finger Tip Unit (FTU) EMLA for 30 minutes; Intervention D: 1 Finger Tip Unit (FTUs) EMLA only and PVA-containing PET Sham Patch

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

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

Also known as: EMLA topical cream

Intervention C: Microneedle with 1 Finger Tip Units (FTUs) EMLA for 15 minutes

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

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

Also known as: EMLA topical cream

Intervention B: Microneedle with 0.5 Finger Tip Unit (FTU) EMLA for 30 minutes

Sham Patch DEVICE

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.

Also known as: Polyvinyl Alcohol (PVA)-containing Polyethylene Terephthalate (PET) Sham Patch

Intervention D: 1 Finger Tip Unit (FTUs) EMLA only and PVA-containing PET Sham Patch

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged at least 6 to 17 years old
• Patients requiring venous cannulation for blood transfusion

You may not qualify if:

• Patients with a previous history of sensitization or allergy to EMLA cream
• Patients with a previous history of allergy to materials used in the study (e.g. Polyvinyl Alcohol (PVA), Polyethylene Terephthalate (PET), Maltose, Electrodes and Plaster constituents)
• Patients receiving other forms of analgesic agents within 24 hours prior to the cannulation procedures
• Patients with generalized skin disorders / rash
• Patients who are agitated or aggressive

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead
• Institue of Microengineering and Nanoelectronics (IMEN), Universiti Kebangsaan Malaysia: collaborator
• Universiti Kebangsaan Malaysia Medical Molecular Biology Institute (UMBI): collaborator

Study Sites (1)

Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia (Ukm Medical Centre)

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (18)

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• Daly S, Claydon NCA, Newcombe RG, Seong J, Addy M, West NX. Randomised controlled trial of a microneedle patch with a topical anaesthetic for relieving the pain of dental injections. J Dent. 2021 Apr;107:103617. doi: 10.1016/j.jdent.2021.103617. Epub 2021 Feb 23.

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MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• FOOK-CHOE CHEAH, MD, MRCPCH, PhD

  HOSPITAL CANSELOR TUANKU MUHRIZ, UNIVERSITI KEBANGSAAN MALAYSIA MEDICAL CENTER

  PRINCIPAL INVESTIGATOR

• AZRUL A HAMZAN, BSc, PhD

  INSTITUTE OF MICROENGINEERING AND ELECTRONICS (IMEN), UKM

  PRINCIPAL INVESTIGATOR

• CHANG FU DEE, BSc, PhD

  INSTITUTE OF MICROENGINEERING AND ELECTRONICS (IMEN), UKM

  PRINCIPAL INVESTIGATOR

• XIN YUN CHUA, BSc

  HOSPITAL CANSELOR TUANKU MUHRIZ, UKM (UNIVERSITI KEBANGSAAN MALAYSIA MEDICAL CENTRE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: A Sham PVA-PET Patch that has the same size and structure as the maltose microneedle will be used. The participants, care providers and outcome assessors will not be able to distinguish between the maltose and sham patch due to their similar size and structure. One of the study investigators (Ooi Kai Shen) will not be masked since the person will be instituting the interventions. However, the study investigator (Ooi Kai Shen) is not one of the outcome assessors or care providers for the study participants.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 14, 2021
• Study Start: September 15, 2021
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD will be made available to the public without any time frame limitation
• Access Criteria: No access criteria are required. The data will be made available to the public, for all types of analyses for each study outcome measure, via the Harvard Dataverse repository, without requiring any access password or special access link.

Locations

MY (1)