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

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Drooling Reduction Intervention randomised trial (DRI): comparing the efficacy and acceptability of hyoscine patches and glycopyrronium liquid on drooling in children with neurodisability
  1. Jeremy R Parr1,2,
  2. Emma Todhunter1,
  3. Lindsay Pennington3,
  4. Deborah Stocken4,
  5. Jill Cadwgan1,2,
  6. Anne E O’Hare5,
  7. Catherine Tuffrey6,
  8. Jane Williams7,
  9. Mike Cole4,
  10. Allan F Colver3
  1. 1 Institute of Neuroscience, Newcastle University, Newcastle Upon Tyne, UK
  2. 2 The Great North Children’s Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK
  3. 3 Institute of Health and Society, Newcastle University, Newcastle Upon Tyne, UK
  4. 4 Biostatistics Research Group, Institute of Health and Society, Newcastle University, Newcastle Upon Tyne, UK
  5. 5 Salvesen Mindroom Centre, University of Edinburgh, Edinburgh, UK
  6. 6 Child Health Services, Solent NHS Trust, Southampton, UK
  7. 7 Nottingham Children’s Hospital, Nottingham University Hospitals NHS Trust, Nottingham, UK
  1. Correspondence to Dr Jeremy R Parr, Institute of Neuroscience, Newcastle University, Framlington Place, Newcastle-upon-Tyne NE2 4HH, UK; jeremy.parr{at}ncl.ac.uk

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 ISRCTN75287237; EUDRACT: 2013-000863-94; Medicines and Healthcare Products Regulatory Agency: 17136/0264/001-0003

  • drooling
  • saliva
  • treatment
  • children
  • neurodisability

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/archdischild-2017-313763

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    Footnotes

    • Contributors JRP was the chief investigator and planned and led the trial. ET undertook most of the telephone consultations to adjust medication and fielded enquires from families (supported by JRP and AFC, who also discussed management with families). DS supervised statistical analyses and wrote statistical aspects of the manuscript. MC contributed to statistical analysis. LP contributed to planning, led on the qualitative work and undertook some discussions with families. JC and CT recruited patients. AEO’H and JW were involved in study design and recruited patients. AC planned the study and was involved in recruiting sites and managing the study. All authors had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. All authors critically reviewed the manuscript and approved the final version.

    • Funding The Castang Foundation; WellChild; The British Academy of Childhood Disability (Polani Fund) and The Children’s Foundation.

    • Competing interests None declared.

    • Ethics approval Newcastle and North Tyneside1 Research Ethics Committee: 13/NE/0078.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Patient level data and full dataset will be available from the corresponding author once all planned data analysis is complete. Participants’ consent for sharing identifiable data was not obtained; the presented data are anonymised and risk of identification is very low.