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Transdermal Maltose-Based Microneedle Patch as Adjunct to Enhance Topical Anesthetic before Intravenous Cannulation
Muhammad Irfan Abdul Jalal1, Kai Shen Ooi2, Kai Cheong Foo2
1UKM Medical Molecular Biology Institute, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur 56000, Malaysia.
Insights
Microneedles may improve pain relief for children during IV cannulation. This study tested EMLA cream with dissolvable microneedles to enhance absorption and reduce pain, potentially speeding up the process in busy clinics.
Area of Science:
- Pediatric Anesthesiology
- Dermatology
- Biomaterials Science
Background:
- Intravenous cannulation causes significant pain and distress in pediatric patients.
- Topical anesthetics like EMLA (eutectic mixture of local anesthetics) are used, but absorption can be slow and incomplete.
- Current application times for EMLA may be impractical in fast-paced clinical settings.
Purpose of the Study:
- To evaluate the efficacy of dissolvable maltose microneedles in enhancing EMLA absorption for pediatric IV cannulation.
- To compare pain scores and skin conductance using different EMLA concentrations and microneedle application times.
- To assess the feasibility of microneedle-assisted EMLA for reducing procedural pain in children.
Main Methods:
- A randomized phase II cross-over trial involving 26 pediatric patients (6-18 years) with thalassemia requiring blood transfusions.
- Four intervention groups: EMLA with microneedles (1 FTU/30min, 0.5 FTU/30min, 1 FTU/15min) and EMLA with a sham patch (1 FTU/30min).
- Pain was assessed using Visual Analogue Scale (VAS) scores and skin conductance algesimeter index via PainMonitor™.
Main Results:
- The study aims to compare pain outcomes between EMLA application with and without microneedle patches.
- Differences in EMLA dosage and application duration will be analyzed for their impact on pain reduction.
- Skin conductance will serve as an objective measure of pain perception.
Conclusions:
- Dissolvable microneedles show promise for improving topical anesthetic efficacy in pediatric procedures.
- This approach could reduce pain and anxiety associated with IV cannulation.
- Optimizing EMLA delivery via microneedles may offer a more efficient pain management strategy in pediatric healthcare.
Abstract:
Intravenous cannulation is experientially traumatic to children. To minimize this, EMLA® is applied on the would-be-cannulated area before IV cannula insertion. However, the time to achieve its maximum efficacy may be affected due to incomplete cutaneous absorption and the duration of application. The latter may be a limiting factor in a busy healthcare facility. The usage of dissolvable maltose microneedles may circumvent this problem by introducing micropores that will facilitate EMLA® absorption. A randomized phase II cross-over trial will be conducted to compare the Visual Analogue Scale (VAS) pain scores and skin conductance algesimeter index between 4 different interventions (1 fingertip unit (FTU) of EMLA® with microneedle patch for 30 min before cannulation; 0.5 FTU of EMLA® with microneedle patch for 30 min; 1 FTU of EMLA® with microneedle for 15 min; 1 FTU of EMLA® with sham patch for 30 min). A total of 26 pediatric patients with thalassemia aged between 6 and 18 years old and requiring blood transfusion will be recruited in this trial. During the visits, the VAS scores and skin conductance algesimeter index at venous cannulation will be obtained using the VAS rulers and PainMonitor™ machine, respectively. The trial will commence in August 2021 and is anticipated to end by August 2022.
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