Pharmaceutical Care Department, King Abdullah Specialized Children Hospital, Ministry of National Guard, Riyadh, Saudi Arabia.
King Abdullah International Medical Research Center (KAIMRC), Ministry of National Guard-Health Affairs, Riyadh, Saudi Arabia.
BMC Pediatr. 2020 Sep 17;20(1):437. doi: 10.1186/s12887-020-02336-x.
Drooling is common in children with neurological disorders, but its management is very challenging, Scopolamine transdermal patch (STP) appears to be useful in controlling drooling, although it is not approved for this indication and there are limited clinical studies about its effectiveness. This study aimed (1) to assess the impact of STP use on the severity of drooling and on the frequency of emergency department (ED) and hospital readmission (RA) visits related to drooling, and (2) to determine the level of family satisfaction with STP when used in children with neurological disorders.
This is a retrospective cohort study of all pediatric patients aged 3-14 years, with non-progressive neurodevelopmental disability, who used STP for more than one year during the period between April 2015 and July 2018 (n = 44). Data on demographics, clinical status, comorbidities, STP dose and duration, other medications, ED and RA visits were collected. Follow-up phone-call interviews with parents/caregivers were performed using a parent-reported frequency and severity rating scale of sialorrhea. Absolute and relative risk reductions were calculated to assess the impact of STP on ED and RA visits. Significance was considered at p-value of ≤ 0.05.
STP use showed significant reduction in severity of drooling (p < 0.001), wiping of the child's mouth (p < 0.001), bibs or clothing changes (p < 0.001), choking and aspiration of saliva (p = 0.001). The Relative Risk Reduction of the drooling-related ED and RA visits were 86% and 67% respectively. Nearly two-thirds (60%) of caregivers were satisfied with using STP.
This is the first study of its kind done in Saudi Arabia demonstrating favorable impact of STP use by children on the consequences associated with drooling and with the frequency of ER and RA visits due to drooling. Development of a medication use protocol is recommended to standardize STP treatment in order to optimize its effectiveness. This study serves as baseline information for future prospective interventional studies.
流涎是神经发育障碍儿童的常见问题，但管理非常具有挑战性。东莨菪碱透皮贴剂（STP）似乎可有效控制流涎，尽管其未获批用于该适应证，且关于其疗效的临床研究有限。本研究旨在：（1）评估 STP 应用对流涎严重程度的影响，以及对与流涎相关的急诊（ED）和住院再入院（RA）的影响；（2）评估 STP 用于神经发育障碍儿童时，家庭对其的满意度。
这是一项回顾性队列研究，纳入了 2015 年 4 月至 2018 年 7 月期间年龄为 3-14 岁、神经发育无进行性残疾、使用 STP 超过 1 年的所有儿科患者（n=44）。收集了人口统计学、临床状况、合并症、STP 剂量和持续时间、其他药物、ED 和 RA 就诊的资料。对父母/照料者进行了电话随访，使用家长报告的流涎严重程度和频率评分量表进行评估。为评估 STP 对 ED 和 RA 就诊的影响，计算了绝对和相对风险降低。当 p 值≤0.05 时认为差异具有统计学意义。
STP 应用可显著降低流涎严重程度（p<0.001）、擦拭儿童口腔（p<0.001）、换围嘴或衣物（p<0.001）、呛咳和唾液吸入（p=0.001）的频率。与流涎相关的 ED 和 RA 就诊的相对风险降低分别为 86%和 67%。近三分之二（60%）的照料者对使用 STP 表示满意。
这是沙特阿拉伯开展的首例此类研究，表明 STP 应用可显著改善儿童流涎相关后果，减少与流涎相关的 ED 和 RA 就诊次数。建议制定药物使用方案，以规范 STP 治疗，从而优化其疗效。本研究为未来的前瞻性干预性研究提供了基线资料。
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