SUBLINGUAL USE OF ATROPINE IN CONTROLLING DROOLING IN CHILDREN WITH CEREBRAL PALSY: A DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL

INTERVENTION: Experimental Drug,Placebo Comparator Drug Intervention: Baseline assessment: Before initiating the treatment, baseline measurements of drooling will be done by applying Drooling Impact Scale (DIS) for all patents meeting the inclusion criteria. Discontinuation from study: In case of any side effect will be observed, immediately stop the medication and patient will be managed accordingly with withdrawal from study Experimental Group: Patients in the experimental group will be administered sublingual atropine (0.5 % ophthalmic solution) with dosage of 1 sublingual drop (for children weight 10 kg ‐19 kg) and 2 sublingual drops (for children weight 20 kg or above).2 Three doses will be given during day time at 6 ‐hour interval. 2 Dosage will be carefully monitored to avoid any adverse effects. After 30 minutes of sublingual administration of atropine heart rate, blood pressure and temperature will be monitor.1‐2 Meanwhile parents will be counselled regarding other side effect including dry mouth, palpitation, urinary retention, facial redness, hallucination, disorientation, constipation and chest pain. ,Controlled Group: To maintain the double‐blind nature of the trial, identical‐looking preparations of atropine and a placebo will be used. Normal saline will be selected as the placebo medication and it will be used in the identical size, shape, and color of the eye drops bottle. Both the patients and the medical staff administering the treatments will be remain unaware of which group each participant belongs to throughout the study period. Discontinuation from study: In case of any side effect will be observed, immediately stop the medication and patient will be managed accordingly with withdrawal from study SUBLINGUAL ATROPINE ADMINISTRATION,SUBLINGUAL NORMAL SALINE CONDITION: sublingual atropine , cerebral palsay , drooling Sublingual Use of Atropine in Controlling Drooling in children with Cerebral Palsy ; sublingual atropine , cerebral palsay , drooling PRIMARY OUTCOME: efficacy of sublingual atropine in reducing drooling in children with cerebral palsy. BASE LINE ASSESMENT AND AFTER 7 DAYS AT THE END OF INTERVENTION DROOLING IMPACT SCALE (QUALITATIVE) SECONDARY OUTCOME: Quality of life , at the end of 7 days of intervention DROOLING IMPACT SCALE ,Safety and tolerability BASE LINE AND AT THE END OF 7 DAYS OF INTERVENTION MONITORING OF SDIE EFECT ,Effects on feeding and swallowing BASE LINE AND 7 DAYS AFTER INTERVENTION DROOLING IMPACT SCALE INCLUSION CRITERIA: 1) Age 4 ‐15 years 2) All patient with Cerebral palsy with excessive Drooling According to Operational definition 3) Previously not used any medication or any therapy for drooling 4) Weight more than 10 kg 5)Electrocardiogram normal