10/4/2023 0 Comments Fresh patch![]() The use of topical systems (formerly known as patches) for the administration of NSAIDs has several key advantages, including drug delivery directly to the injury site, markedly reduced plasma concentrations relative to systemic formulations, lower risk of systemic AEs, and avoidance of first-pass metabolism and potential drug-drug interactions. Topical non-steroidal anti-inflammatory drugs (NSAIDs) are effective in a variety of acute and chronic pain conditions, including osteoarthritis, and systematic reviews of randomized, double-blind, comparative studies have shown topical diclofenac to be effective for acute and chronic pain, including strains and sprains, with low rates of systemic or local adverse events (AEs). ![]() Clinical Trial RegistrationĬ identifier NCT02132247. The FLECTOR topical system safely and effectively provided pain relief for minor soft tissue injuries in the pediatric population, with minimal systemic nonsteroidal anti-inflammatory drug exposure and low potential risk of local or systemic adverse events. The diclofenac plasma concentration tended to be higher in the younger age group compared with older patients: 1.83 versus 1.46 ng/mL at the first assessment and 2.49 versus 1.11 ng/mL at the last assessment ( p = 0.002). Reduction in pain during the study was somewhat greater for patients aged 6–11 versus 12–16 years ( p < 0.011). Fourteen adverse events (none serious) in nine patients (8.7%) were considered possibly treatment-related. The maximum tolerability score experienced by any patient was 1 (faint redness). Resultsġ04 patients were enrolled 52 were 6–11 years old, and 52 were 12–16 years old (mean age 11.6 years). Key secondary endpoints were diclofenac plasma concentrations and analgesic efficacy. The primary endpoint was local tolerability and systemic safety. The FLECTOR topical system was applied twice daily until pain resolution or Day 14. This was an open-label, single-arm, phase IV study at ten USA-based family medicine or pediatric practices in children aged 6–16 years with a clinically significant minor soft tissue injury sustained within the preceding 96 h and at least moderate spontaneous pain on the Wong-Baker FACES ® Pain Rating Scale. This study assessed the safety and efficacy of the FLECTOR (diclofenac epolamine) topical system in children. ![]() It does not store any personal data.A topical formulation of diclofenac (FLECTOR diclofenac epolamine topical system (FDETS)) is approved in adults for the treatment of acute pain due to minor strains, sprains, and contusions however, its safety and efficacy have not been investigated in a pediatric population. The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. The cookie is used to store the user consent for the cookies in the category "Performance". This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other. ![]() The cookies is used to store the user consent for the cookies in the category "Necessary". The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". The cookie is used to store the user consent for the cookies in the category "Analytics". These cookies ensure basic functionalities and security features of the website, anonymously. Necessary cookies are absolutely essential for the website to function properly.
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