Randomized double-blind crossover trial of a transdermal maltose dissolvable microneedle patch for topical anesthesia before intravenous cannulation for thalassemia children

Sep 30, 2026

Efficacy and safety of a transdermal dissolvable microneedle array patch (MNAP) for delivering topical anesthesia were evaluated in transfusion-dependent thalassemia children undergoing intravenous cannulation for blood transfusion. A double-blind, randomized crossover trial enrolled 19 children (ages 6–17) receiving MNAP with varying EMLA finger-tip-unit doses/times or sham MNAP before cannulation. Primary and secondary pain outcomes were VAS and skin conductance algesimeter index (SCAI) measured immediately after cannulation. MNAP plus 1 FTU EMLA for 30 min lowered VAS versus sham, while SCAI differences were not significant and SCAI showed no correlation with VAS; only one mild pruritus adverse event occurred. MNAP is a safe adjunct enhancing EMLA analgesic effectiveness before IVC.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages13

Reading Time33 min

AccessFree to download

Background

Topical anesthesia and procedural pain in thalassemia children

Microneedle-based transdermal delivery and maltose

Objective pain assessment

Limitations of self-reported scales

Skin conductance algesimeter index (SCAI)

Methods

Double-blind randomized crossover design

Intervention arms and dosing schedules

Pain endpoints and measurement timing

Results

VAS and SCAI outcomes after intravenous cannulation

Adverse events

Conclusion

[www. nature.com/scientificreports](www. nature.com/scientificreports) OPEN Randomized double-blind crossover trial of a transdermal maltose dissolvable microneedle patch for topical anesthesia before intravenous cannulation forthalassemia children Muhammad Irfan Abdul Jalal1, Kai ShenOoi2, Kai Cheong Foo2, Azrul Azlan Hamzah3􀀍, Chang Fu Dee3, Poh ChoonOoi3, Muhammad Ramdzan Buyong3, Arifah Syahirah Abdul Rahman3, Teck Yew Low1,4, Xin Yun Chua5, Doris Sie Chong Lau2 & Fook Choe Cheah2,6􀀍 The efficacy and safety of transdermal dissolvable microneedle array patch (MNAP) in enhancing topical anesthesia delivery was studied in transfusion-dependent thalassemia children who had intravenous cannulation (IVC) for blood transfusion. We also compared the use of skin conductance algesimeter index (SCAI) as a pain assessment tool against the visual analog score (VAS) in these children with ages between 6 and 17 years, who had the topical anesthetic cream (EMLA) applied on the hand dorsum before IVC. This was a double-blind, randomized crossover trial involving 19 children with each child randomized to four intervention arms sequentially: MNAP and 1 finger-tip-unit (FTU) EMLA applied for 30 min (A), MNAP and 0.5 FTU EMLA for 30 min (B); MNAP and 1 FTU EMLA for 15 min (C); and no MNAP (sham) patch and 1FTU EMLA for 30 min (D), before IVC. The primary and secondary endpoints were, respectively, VAS and SCAI scores measured immediately after IVC. The MNAP with 1 FTU EMLA for 30 min resulted in significantly lower VAS scores than sham patch [MeanMNAP (SE),1.839 (0.560) vs. [Meansham (SE): 3.063 (0.534); p = 0.048], but not SCAI [MeanMNAP (SE): 0.200 (0.024) versus Meansham (SE): 0.203 (0.026); p = 0.926]. The SCAI was not significantly correlated with VAS for all groups (r = -0.040 to 0.378; p (all) > 0.05). Only 1 participant reported pruritus as a mild adverse event. The MNAP is a safe adjunct method to enhance effectiveness of pain relief from EMLA skin anesthetic before IVC. Keywords Microneedle, Dissolvable, Thalassemia, Pain, Skin anesthetic, Visual analog score, Skin conductance algesimeter index, Intravenous cannulation, Topical, Anesthesia Thalassemia is one of the most commonly inherited hematological conditions afflicting Malaysian children. It is estimated that thalassemia affects 2.1 per 1000 live births, and the majority of them are bloodtransfusion dependent and on chelation therapy1,2. Due to the maturational process in the physiology of theneurophysiological system, children may be more vulnerable to acute and long term procedural-related pain, which may lead to avoidance behavior and later poor therapeutic compliance3,4. Topical anesthesia in the form of 1UKM Medical Molecular Biology Institute, Universiti Kebangsaan Malaysia, JalanYaacob Latif, 56000 Kuala Lumpur, Malaysia. 2Department of Paediatrics, Faculty of Medicine, Universiti Kebangsaan Malaysia, Hospital Pakar KanakKanak, Jalan Yaacob Latif, 56000 Kuala Lumpur, Malaysia. 3Institute of Microengineering and Nanoelectronics, Universiti Kebangsaan Malaysia, 43600 Bangi, Malaysia. 4Sir Jeffrey Cheah Sunway Medical School, Faculty of Medical and Life Sciences, Sunway University, 47500 Bandar Sunway, Malaysia. 5Pharmacy Department, Hospital Canselor Tuanku Muhriz, Jalan Yaacob Latif, 56000 Kuala Lumpur, Malaysia. 6Placenta and Perinatal Research Group, Universiti Kebangsaan Malaysia, 43600 Bangi, Malaysia. 􀀍 email: [azlanhamzah@ukm.edu.my](azlanhamzah@ukm.edu.my); [cheahfc@hctm.ukm.edu.my](cheahfc@hctm.ukm.edu.my) [www. nature.com/scientificreports/](www. nature.com/scientificreports/) pre-procedural skin application of local anesthetic agents such as the eutectic mixture of lidocaine and prilocaine (EMLA) is the standard pain relief method before skin puncture, but its effectiveness is time-dependent and likely compromised in a busy clinic setting. Thus, a shorter time from application to the desired anesthetic effect will not only ensure patient sat

FAQs

What intervention was tested in the trial?

The trial tested a transdermal dissolvable microneedle array patch (MNAP) combined with topical EMLA at different finger-tip-unit doses and application times, compared with a sham MNAP patch plus EMLA before intravenous cannulation.

How were pain outcomes measured?

Pain intensity was assessed immediately after intravenous cannulation using two primary outcomes: the Visual Analog Score (VAS) and the skin conductance algesimeter index (SCAI).

Did SCAI track the same pain pattern as VAS?

No. SCAI was not significantly correlated with VAS across all groups, and the between-group SCAI differences were not significant.

Sep 30, 2026

Uploaded by Valentina