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

• Status: Recruiting
• Trial end date: 2022-08-11
• Target enrollment: 0
• Participant gender: All

Summary

Microneedle (MN) is the mimic of 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universiti Kebangsaan Malaysia Medical Centre
• Collaborators: Institue of Microengineering and Nanoelectronics (IMEN), Universiti Kebangsaan Malaysia; Universiti Kebangsaan Malaysia Medical Molecular Biology Institute (UMBI)
• Treatments: Lidocaine, Prilocaine Drug Combination; Terephthalic acid

Criteria

Inclusion Criteria:

1. Patients aged at least 6 to 17 years old

2. Patients requiring venous cannulation for blood transfusion

Exclusion Criteria:

1. Patients with a previous history of sensitization or allergy to EMLA cream

2. 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)

3. Patients receiving other forms of analgesic agents within 24 hours prior to the cannulation procedures

4. Patients with generalized skin disorders / rash

5. Patients who are agitated or aggressive