Drooling treatment in children with cerebral palsy: a multicenter, controlled, randomized clinical trial

Abstract

Drooling is clinically defined as an excess of saliva that drops beyond the lip margin. It is present in approximately the 40% of the children that suffer Cerebral Palsy (which is defined as a motor dysfunction due to a non-progressive brain lesion during the period of development of the brain). Drooling causes a huge impact on the daily lives of these patients and can also imply heath problems. There are a lot of treatments available for drooling, most of them have proved their effectiveness reducing the amount of drooling, but none of them have proved to be capable of stopping it. In addition, there is a lack of comparative studies between the different options. These days, the main treatment for drooling is based in anticholinergic drugs (such as glycopyrrolate or trihexyphenidyl) despite the amount of side effects that they normally cause. An alternative to these treatments is the injection of botulinum toxine into the salivary glands. This treatment has proved to be effective and safe for the treatment of drooling and also causes fewer side effects than other options. Because of the lack of comparative studies between the different options, it is unknown which is the best treatment option OBJECTIVE: Compare the effectiveness and the side effects of three treatment options for drooling (glucopyrrolate, trihexyphenidyl and botulinum toxine injections) in order to prove that botulinum toxine injections are a better treatment option than the other two providing a better life quality to the patients DESIGN: multicentre, controlled, randomized clinical trial between the years 2016-2020 PARTICIPANTS: children patients (between 4 and 18 years old) with cerebral palsy and drooling with a score =/>30 points in the Drooling Impact Scale, treated in Hospital Universitari Josep Trueta de Girona, Hospital Universitari Vall d’Hebron, Hospital Clínic de Barcelona, Hospital Sant Joan de Déu Barcelona, Hospital Universitario La Paz, Hospital Universitario 12 de octubre, Hospital Universitario Ramón y Cajal and Hospital Infantil Universitario Niño Jesús