Efficacy of scopolamine transdermal patch in children with sialorrhea in a pediatric tertiary care hospital

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Cerebral palsy; Drooling; ER visits; Efficacy; Hospital readmission; Hyoscine; Neurological disorders; Saudi; Scopolamine; Transdermal.