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Published on: December 5, 2025
Ketorolac tromethamine-loaded hydrogel-forming microneedles for pediatric pain relief
Guiyu Huang1, Shuhui Chen2, Yizhi Zhang2
1Academy of Military Medical Sciences, Beijing 100850, China; Henan University, Kaifeng 475004, China.
Insights
New microneedles loaded with ketorolac tromethamine (KT) offer a safe and effective way to manage pediatric pain. This transdermal delivery system provides sustained pain relief, improving treatment compliance for children.
Area of Science:
- Biomaterials Science
- Pharmaceutical Sciences
- Pediatric Pain Management
Background:
- Systemic administration of analgesics in children poses risks to growth and development.
- Developing specialized pediatric pain relief formulations is crucial for treatment compliance.
- Microneedle (MN) technology offers potential for transdermal drug delivery, minimizing systemic side effects.
Purpose of the Study:
- To design, prepare, and evaluate ketorolac tromethamine (KT)-loaded hydrogel-forming microneedles (KT-TMN) for pediatric pain management.
- To investigate the effect of microneedle tip geometry on mechanical strength and performance.
- To assess the analgesic efficacy, safety, and pharmacokinetic profile of the developed KT-TMN system.
Main Methods:
- Methacrylic anhydride-modified hyaluronic acid was used as the matrix for hydrogel-forming microneedles.
- Microneedles with conical, tetrapyramidal, and candle-like tip geometries were fabricated and characterized.
- Mechanical properties, insertion capability, safety, drug release kinetics, analgesic efficacy (acetic acid-induced writhing and hot plate tests), and in vivo pharmacokinetics were evaluated.
Main Results:
- Candle-like microneedles (KT-TMN) demonstrated superior mechanical strength and insertion capability.
- KT-TMN exhibited significant analgesic efficacy in mice, comparable to intravenous ketorolac tromethamine.
- In vivo pharmacokinetic studies showed stable and sustained drug release, indicating effective transdermal delivery.
Conclusions:
- The developed KT-TMN system is a promising transdermal delivery platform for pediatric analgesia.
- This microneedle formulation offers a safer alternative to systemic drug administration, potentially improving pediatric pain management.
- Further research into KT-TMN for pediatric applications is warranted due to its efficacy and favorable pharmacokinetic profile.
Abstract:
Pain is particularly intolerable for children, and the analgesic regimen must be carefully managed, as systemic delivery may lead to serious side effects to growth and development of children. Therefore, the research and development of pain-relieving formulations and administration routes specifically tailored for children are both meaningful and essential to enhance treatment compliance. In this study, ketorolac tromethamine (KT)-loaded hydrogel-forming microneedle (MN) were designed, prepared, and evaluated using methacrylic anhydride -modified hyaluronic acid as the MN matrix. Conical, tetrapyramidal and candle-like tip geometries with distinct profiles were fabricated. The relationship between tip geometry and mechanical strength was systematically evaluated, revealing that the candle-like MN (KT-TMN) exhibits superior mechanical performance. Comprehensive characterization was conducted on the morphology, mechanical properties, insertion capability, safety profile, and drug release kinetics of the MN system. Results from the acetic acid-induced writhing test and hot plate test demonstrated that KT-TMN significantly prolonged pain latency and reduced writhing responses in mice, exhibiting an analgesic efficacy comparable to intravenous administration of KT. In vivo pharmacokinetic studies revealed that KT-TMN enabled stable and sustained drug release, highlighting its potential for transdermal delivery of KT as a pediatric analgesic agent.
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