Trial of Glycopyrronium versus Hyoscine to treat drooling in children

• Research type

  Research Study

• Full title

  A single blind study comparing the efficacy of Glycopyrronium and Hyoscine on drooling in children with neurodisability - DRI Trial (Drooling Reduction Intervention)

• IRAS ID

  121825

• Contact name

  Jeremy Parr

• Sponsor organisation

  Newcastle Upon Tyne Hospitals NHS Foundation Trust

• Eudract number

  2013-000863-94

• ISRCTN Number

  N/A

• Research summary

  Drooling is a common problem in children with neurodisabilities such as cerebral palsy or Down Syndrome. Drooling leads to the facial skin becoming sore, frequent changes of clothes, damage to educational equipment, and often social embarrassment for the child and family. There is no evidence about the relative effectiveness of the two medications most commonly used to reduce droolingThis study aims to identify:- whether Glycopyrronium or Hyoscine is more effective and at what dose - side effects of the medications and how these relate to doseOver 9 months paediatricians, with special interest in neurodisability working in 15 UK centres, will recruit 90 children from out-patient clinics; these children will not have received any medication for drooling. Children will have a non-progressive neurodisability and be less than 16 years old. They will have no contraindications to the medications. Children will be randomised for treatment and medication will be increased, as tolerated for 4 weeks; this will be under the guidance of the Trial Research Paediatrician, working to the study protocol.The Trial Outcome Assessor will collect outcome data before the intervention and then at 4, 12 and 52 weeks. Well established scales of the impact of the medication on family and child will be used. Children of sufficient age and ability (identified with help of local paediatrician and the family) will be asked for their own views in an interview.The results will lead to guidance on: drug doses, intervals for increasing medication, and monitoring of adverse effects. The results have the potential to be adopted immediately because the medications are already in use and surveys of parents and professionals, before the study started, indicates that this trial is needed and the results anticipated with interest.The overall study duration will be 2 years.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  13/NE/0078

• Date of REC Opinion

  21 Mar 2013

• REC opinion

  Favourable Opinion