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Randomized Controlled Trial
. 2018 Apr;103(4):371-376.
doi: 10.1136/archdischild-2017-313763. Epub 2017 Nov 30.

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

Jeremy R Parr  1   2 , Emma Todhunter  1 , Lindsay Pennington  3 , Deborah Stocken  4 , Jill Cadwgan  1   2 , Anne E O'Hare  5 , Catherine Tuffrey  6 , Jane Williams  7 , Mike Cole  4 , Allan F Colver  3
Affiliations
Randomized Controlled Trial

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

Jeremy R Parr et al. Arch Dis Child. 2018 Apr.

Abstract

Objective: Investigate whether hyoscine patch or glycopyrronium liquid is more effective and acceptable to treat drooling in children with neurodisability.

Design: Multicentre, single-blind, randomised controlled trial.

Setting: Recruitment through neurodisability teams; treatment by parents.

Participants: Ninety 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.

Intervention: Children 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 outcomes: Primary 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.

Results: Both 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).

Conclusions: Hyoscine 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 numbers: ISRCTN 75287237; EUDRACT: 2013-000863-94; Medicines and Healthcare Products Regulatory Agency: 17136/0264/001-0003.

Keywords: children; drooling; neurodisability; saliva; treatment.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Consort diagram. ITT, intention to treat.
Figure 2
Figure 2
Mean Drooling Impact Scale scores at baseline, week-4 and week-12 for the intention-to-treat group (with 95% CI).
See this image and copyright information in PMC

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