Drooling Reduction Intervention randomised trial (DRI): comparing the efficacy and acceptability of hyoscine patches and glycopyrronium liquid on drooling in children with neurodisability

• Published in: Archives of disease in childhood 2018-04, Vol.103 (4), p.371-376
• Main Authors: Parr, Jeremy R, Todhunter, Emma, Pennington, Lindsay, Stocken, Deborah, Cadwgan, Jill, O’Hare, Anne E, Tuffrey, Catherine, Williams, Jane, Cole, Mike, Colver, Allan F
• Format: Article
• Language: English
• Subjects: Administration, Oral; Adolescent; Breakdowns; Cerebral Palsy; Child; Child care; Child Health; Child, Preschool; Children; Children & youth; Cholinergic Antagonists - therapeutic use; Disability; Drug Administration Schedule; Evidence-based medicine; Female; Follow-Up Studies; Glycopyrrolate - therapeutic use; Humans; Intervention; Male; Nervous System Diseases - complications; Original; Outcome Measures; Parents; Parents & parenting; Prospective Studies; Recruitment; Saliva; Scopolamine - therapeutic use; Sialorrhea - drug therapy; Sialorrhea - etiology; Side effects; Single-Blind Method; Skin; Statistical analysis; Systematic review; Transdermal Patch; Treatment Outcome
• ISSN: 0003-9888; 1468-2044
• DOI: 10.1136/archdischild-2017-313763

ObjectiveInvestigate whether hyoscine patch or glycopyrronium liquid is more effective and acceptable to treat drooling in children with neurodisability.DesignMulticentre, single-blind, randomised controlled trial.SettingRecruitment through neurodisability teams; treatment by parents.ParticipantsNinety children with neurodisability who had never received medication for drooling (55 boys, 35 girls; median age 4 years). Exclusion criteria: medication contraindicated; in a trial that could affect drooling or management.InterventionChildren were randomised to receive a hyoscine skin patch or glycopyrronium liquid. Dose was increased over 4 weeks to achieve optimum symptom control with minimal side-effects; steady dose then continued to 12 weeks.Primary and secondary outcomesPrimary outcome: Drooling Impact Scale (DIS) score at week-4. Secondary outcomes: change in DIS scores over 12 weeks, Drooling Severity and Frequency Scale and Treatment Satisfaction Questionnaire for Medication; adverse events; children’s perception about treatment.ResultsBoth medications yielded clinically and statistically significant reductions in mean DIS at week-4 (25.0 (SD 22.2) for hyoscine and 26.6 (SD 16) for glycopyrronium). There was no significant difference in change in DIS scores between treatment groups. By week-12, 26/47 (55%) children starting treatment were receiving hyoscine compared with 31/38 (82%) on glycopyrronium. There was a 42% increased chance of being on treatment at week-12 for children randomised to glycopyrronium relative to hyoscine (1.42, 95% CI 1.04 to 1.95).ConclusionsHyoscine and glycopyrronium are clinically effective in treating drooling in children with neurodisability. Hyoscine produced more problematic side effects leading to a greater chance of treatment cessation.Trial registration numbersISRCTN75287237; EUDRACT: 2013-000863-94; Medicines and Healthcare Products Regulatory Agency: 17136/0264/001-0003