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Sialorrhoea

NICE have published its latest guidelines on "Cerebral palsy in the under 25: assessment and management" NICE Guidelines:

Glycopyrronium bromide has a well-established history of use over more than 10 years in the United Kingdom for the treatment of sialorrhoea (chronic pathological drooling) in children with neurological disorders. 

The overall prevalence of significant sialorrhoea in children is estimated at up to 0.6% (Fairhurst, 2011).  However, sialorrhoea is much more common in neurologically impaired children including those with cerebral palsy (CP), the most common motor disability of childhood; estimates of the prevalence of sialorrhoea in these populations range from 10% to 40% (Parr, 2014; Parkes, 2010; Mier, 2000; Van De Heyning, 1980, Reid, 2012) but may be even higher in some subgroups, especially those with quadriplegic CP (Fairhurst, 2011; Tahmassebi, 2003a).

The UK has approximately 23,000 children with cerebral palsy. Reid et al 2012 demonstrated that 40% of children with CP have drooling of which 15% is severe. This equates to 9,200 children with CP and drooling in England of whom 1,380 cases would be classified as severe.   

Uncontrolled sialorrhoea can have negative consequences for health and quality of life (QoL) due to the prodigious rate of salivation (Parr, 2014; Fairhurst, 2011; Mier, 2000; Harris, 1987; Hockstein, 2004; Van De Heyning, 1980; Van der Burg, 2006b).  There may be a perception that chronic drooling is not a significant issue for affected children, but this is far from the truth. Sullivan and Rosenbloom, (1996) stated that persistence of drooling into school age leads to social isolation and the problem can be both practically and socially devastating in adolescence and childhood. Drooling children frequently have chronically irritated, macerated facial skin and in cold months the dampness from saliva is chilly. Dehydration can even become a recurrent problem as a consequence of chronic fluid and nutrient loss.

Books and papers become untidy or damaged in school or at work and electronic devices may malfunction. The ability of motor-impaired individuals to access new and sophisticated electronic technology that can offer them more opportunity to communicate and more independence is severely compromised by uncontrolled sialorrhoea. Inability to control drooling, in the face of peer pressure to do so, can result in substantial loss of self-esteem. Besides being unsightly, concerns related to hygiene and disagreeable odour alienate people. Speech spray from individuals with wet mouths is unpleasant and cough or sneeze can be a social catastrophe.

For those naïve to the problems of the developmentally disabled it requires a conscious learned effort to approach the drooler, enter into conversation or make physical contact. In itself drooling affects the general well-being of individuals and secondarily it may present problems for caregivers. Therefore its early recognition and specific treatment is essential to the overall intervention plan of the multidisciplinary team. The goal is to promote a better quality of life and to improve social interactions. 

Classification of Sialarrhoea

There are several systems employed for the classification of sialorrhoea. A common method, and the one used in many clinical studies, is the modified Teacher's Drooling Scale.

 

Pathophysiology of sialorrhoea

The pathophysiology of sialorrhea is not clear. However, the following five factors have an impact on the complex and coordinated process of swallowing and are thought to contribute in varying degrees to drooling in individuals with neurological disorders (Blasco 1992; Mier 2000):

·       Integrity of oral structures;

·       Oropharyngeal motor function;

·       Orofacial sensory perception and feedback;

·       Rate of saliva secretion; and

·       Cognitive awareness of salivary spill.

Saliva production and swallowing is an automatic act. However, it is dependent on the ability to feel the build-up of saliva within the mouth and relies upon the normal movement of the tongue to collect it and transfer it to the back of the mouth for swallowing. A child will typically produce 1-1.5 liters of salvia everyday with the production predominantly occurring in three pairs of salivary glands: the submandibular, sublingual and parotid. The submandibular glands account for 65‑70% of unstimulated production of saliva so are the primary source of saliva in sialorrhoea (Fairhurst 2011, Erasmus 2009).

Management of Sialorrhoea

Several non-invasive options are available as a first-line management of sialorrhea (directed at the cause), such as practical aids, speech therapy, physiotherapy.

Further therapeutic options of increasing invasiveness exist, such as anticholinergic medication, botulinum toxin or surgical removal or ligation of some of the salivary glands.

Drug therapy is aimed at decreasing the volume of saliva without addressing impaired swallowing. Historically, a range of drugs with anticholinergic (antimuscarinic) actions have been used in an attempt to control sialorrhea.

Anticholinergic drugs work by decreasing the volume of saliva secreted from the salivary glands and thus the severity of drooling. Hyoscine (scopolamine), benztropine mesylate and benzhexol have all been shown to be useful for controlling drooling in children with neurological disorders. However, their lack of selectivity leads to widespread, undesirable, and often poorly tolerated central and peripheral effects, including restlessness, irritability, drowsiness, constipation, urinary retention, and flushing. 

Glycopyrronium bromide is a water-soluble synthetic quaternary amine. It is a peripheral antimuscarinic (anticholinergic) agent. Glycopyrronium bromide acts as a competitive antagonist at muscarinic receptors in the autonomic nervous system. One of the pharmacological actions of all anticholinergic drugs is the reduction of secretions through antagonism of cholinergic M3 stimulation (Tscheng et al. 2002). Glycopyrronium bromide, administered via the intravenous (i.v.), intramuscular (i.m.), and oral routes, has been shown to reduce salivary secretions in healthy adult volunteers (Mirakhur, 1978a; Mirakhur, 1980) and surgical patients (Mirakhur, 1979b; Ali-Melkkilä, 1989; Ali-Melkkilä, 1990a). Compared with atropine, glycopyrronium bromide is selective and 6-times more potent with a longer duration of effect on salivary secretions.

Sialanar (glycopyrronium 320micrograms/ml) equivalent to 400micrograms/ml (2mg/5ml) glycopyrronium bromide, was licensed for children throughout Europe on 15th September 2016, for the symptomatic treatment of severe sialorrhoea aged 3 years and over.

References

 Ali‑Melkkilä T, Kaila T, Kanto J. Glycopyrrolate: pharmacokinetics and some pharmacodynamic findings. Acta Anaesthesiol Scand 1989;33:513-7.

Ali‑Melkkilä TM, Kaila T, Kanto J, Iisalo E. Pharmacokinetics of IM glycopyrronium. Br J Anaesth 1990a;64:667-9.

Erasmus CE, Van Hulst K, Rotteveel LJ, et al. Drooling in cerebral palsy: hypersalivation or dysfunctional oral motor control? Dev Med Child Neurol 2009;51:454-9.

Fairhurst CB, Cockerill H. Management of drooling in children. Arch Dis Child Educ Pract Ed 2011;96:25-30.

Harris SR, Purdy AH. Drooling and its management in cerebral palsy. Dev Med Child Neurol 1987;29:807-11.

Hockstein NG, Samadi DS, Gendron K, Handler SD. Sialorrhoea: a management challenge. Am Fam Physician 2004;69:2628-34.

Mier RJ, Bachrach SJ, Lakin RC, et al. Treatment of sialorrhea with glycopyrrolate: A double-blind, dose-ranging study. Arch Pediatr Adolesc Med 2000;154:1214-8.

 Mirakhur RK, Dundee JW, Jones CJ. Evaluation of the anticholinergic actions of glycopyrronium bromide. Br J Clin Pharmacol 1978a;5:77-84.

Mirakhur RK, Dundee JW. Cardiovascular changes during induction of anaesthesia. Influence of three anticholinergic premedicants. Ann R Coll Surg Engl 1979b;61:463-9.

 Mirakhur RK, Dundee, JW. Comparison of the effects of atropine and glycopyrrolate on various end-organs. J R Soc Med 1980;73:727-30.

Parkes J, Hill N, Platt MJ, Donnelly C. Oromotor dysfunction and communication impairments in children with cerebral palsy: a register study. Dev Med Child Neurol 2010;52:1113-9.

Parr JR, Weldon E, Pennington L, et al. The drooling reduction intervention trial (DRI): a single blind trial comparing the efficacy of glycopyrronium and hyoscine on drooling in children with neurodisability. Trials 2014;15:60.

Reid, SM, McCutcheon, J, Reddihough, DS, Johnson, H. Prevalence and predictors of drooling in 7- to 14-year-old children with cerebral palsy: a population study. Developmental Medicine and Child Neurology 2012; 54;1032-1036.

Sullivan B, Rosenbloom L. Feeding the disabled child. Clinics in developmental medicine No. 140 1996.

Tahmassebi JF, Curzon ME. Prevalence of drooling in children with cerebral palsy attending special schools. Dev Med Child Neurol 2003a;45:613–7.

Tscheng DZ. Sialorrhea - therapeutic drug options. Ann Pharmacother 2002;36:1785‑90.

Van der Burg JJ, Jongerius PH, Van Hulst K, et al. Drooling in children with cerebral palsy: effect of salivary flow reduction on daily life and care. Dev Med Child Neurol 2006b;48:103-7.

Van De Heyning PH, Marquet JF, Creten WL. Drooling in children with cerebral palsy. Acta Otorhinolaryngol Belg 1980;34(6):691-705.

Zeller RS, Lee H-M, Cavanaugh PF, Davidson J. Randomized phase III evaluation of the efficacy and safety of a novel glycopyrrolate oral solution for the management of chronic severe drooling in children with cerebral palsy or other neurologic conditions. Ther Clin Risk Manag 2012a;8:15-23.

Zeller RS, Davidson J, Lee H-M, Cavanaugh PF. Safety and efficacy of glycopyrrolate oral solution for management of pathologic drooling in pediatric patients with cerebral palsy or other neurologic conditions. Ther Clin Risk Manag 2012b; 8:25-32.