Studies In Progress

The efficacy of sublingually delivered ophthalmic atropine for the

Investigators & Staff: Adam Rapoport, Christine Newman, Jeremy Friedman

Does sublingually delivered ophthalmic atropine solution decrease oral secretions in children?  This study will evaluate this through a series of N-of-1 double-blind randomized-controlled trials.  Furthermore, as the use of ophthalmic atropine sublingually is off-label, this study will attempt to draw conclusions regarding the optimal dosing of sublingual atropine in children and comment on its adverse effects.

Funding Agency

Not yet determined

Summary

Excess oral secretions are a common problem in children with chronic neurologic conditions,1, 2 often becoming more burdensome towards the end-of-life.3 Neurologically intact children may also have difficulty managing their saliva at the end-of-life.4 Anticholinergic drugs to control drooling have been criticized for their variable efficacy and systemic side effects, including behavioural changes and urinary retention.5 Surgical treatments require technical expertise, may lead to irreversible complications, and may not be considered appropriate for palliative patients.6 The use of sublingually delivered atropine to decrease oral secretions has many potential benefits including ease of delivery, low cost and primarily direct local action.  This study will evaluate the efficacy of sublingual atropine for the control of oral secretions in children through a series of N-of-1 double-blind randomized-controlled trials.

Inpatients at the Hospital for Sick Children, a tertiary care centre, identified as having problems with oral secretions will be recruited for this study.  Each patient will undergo 2 phases of the study.  During Phase 1, patients will be given 1 drop of sublingual atropine of various concentrations, every 4 hours, to determine their “optimal dose”.  Phase 2 of the study, which will be conducted in the outpatient setting, will consist of paired-treatments of atropine and placebo in a double-blind randomized manner.  In this N-of-1 methodology, each patient will undergo five sets of paired-treatments, each time acting as their own control subject.

In both Phase 1 & 2 of the study, the effect on oral secretions will be evaluated using subjective measures only, which some experts consider to be the most important measure for this problem.7 Upon study enrolment, patients or their caregivers will complete a baseline questionnaire indicating the frequency and severity of their drooling, and indicate the primary negative impact of this problem (ie. choking, frequent shirt changes, etc.).  The questionnaire will be completed following each treatment period, and results will be analyzed for each individual patient as well as for the pooled group of N-of-1 trials.  The questionnaire will also enquire about adverse effects experienced during the trial.

What we Learned

In progress

What’s Next

In progress

Reference List

Sullivan PB, Lambert B, Rose M, Ford-Adams M, Johnson A, Griffiths P. Prevalence and severity of feeding and nutritional problems in children with neurological impairment: Oxford Feeding Study. Dev Med Child Neurol. Oct 2000;42(10):674-680.

Waterman ET, Koltai PJ, Downey JC, Cacace AT. Swallowing disorders in a population of children with cerebral palsy. Int J Pediatr Otorhinolaryngol. Jul 1992;24(1):63-71.

Hunt AM. A survey of signs, symptoms and symptom control in 30 terminally ill children. Dev Med Child Neurol. Apr 1990;32(4):341-346.

Goldman A, Hewitt M, Collins GS, Childs M, Hain R. Symptoms in children/young people with progressive malignant disease: United Kingdom Children’s Cancer Study Group/Paediatric Oncology Nurses Forum survey. Pediatrics. Jun 2006;117(6):e1179-1186.

Jongerius PH, van Tiel P, van Limbeek J, Gabreels FJ, Rotteveel JJ. A systematic review for evidence of efficacy of anticholinergic drugs to treat drooling. Arch Dis Child. Oct 2003;88(10):911-914.

Lal D, Hotaling AJ. Drooling. Curr Opin Otolaryngol Head Neck Surg. Dec 2006;14(6):381-386.

Blasco PA. Management of drooling: 10 years after the Consortium on Drooling, 1990. Dev Med Child Neurol. Nov 2002;44(11):778-781.