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

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 15, 2021

Primary Completion Date

August 11, 2022

Study Completion Date

August 11, 2022

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.

Trial Locations (1)

56000

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

All Listed Sponsors
collaborator

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

UNKNOWN

collaborator

Universiti Kebangsaan Malaysia Medical Molecular Biology Institute (UMBI)

UNKNOWN

lead

Universiti Kebangsaan Malaysia Medical Centre

OTHER

NCT05078463 - Efficacy of Transdermal Microneedle Patch for Topical Anesthesia Enhancement in Paediatric Thalassemia Patients | Biotech Hunter | Biotech Hunter