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1.
Trials ; 15: 60, 2014 Feb 17.
Article in English | MEDLINE | ID: mdl-24533890

ABSTRACT

BACKGROUND: Drooling saliva is a common problem in children with neurodevelopmental disorders. The negative consequences of drooling include skin breakdown, dehydration, and damage to clothing and equipment. Children and families often suffer social embarrassment due to drooling. There is no evidence about the relative effectiveness, side effect profiles or patient acceptability of the two medications most commonly used to reduce drooling - glycopyrronium and hyoscine. Consequently, there is no consensus or guideline to aid clinical decisions about which drug to use, and at what dose. METHODS/DESIGN: A multi-centre, randomised trial of treatment with glycopyrronium or hyoscine in children with problematic drooling and non-progressive neurodisability. Ninety children aged between 3 and 15 years who have never received medication for drooling will be stratified by severity of drooling and care centre. Randomisation to receive treatment with glycopyrronium or hyoscine will be computer generated from the trial randomisation website. Dose adjustment and side effect monitoring will occur via telephone consultation. Medication arm will be known to participants and clinicians but not the Trial Outcome Assessor.The primary outcome measure is the Drooling Impact Scale score at four weeks, at which time all children will be on the maximum tolerated dose of their medication. Secondary outcome measures include change in Drooling Impact Scale score between baseline, 4, 12 and 52 weeks, change in Drooling Severity and Frequency Scale score and difference between groups in the Treatment Satisfaction Questionnaire for Medication score. A structured interview with children and young people of sufficient age, cognitive and communication ability will explore their perceptions of drooling and the effectiveness and acceptability of the medications. DISCUSSION: The primary objective of the study is to identify whether glycopyrronium or hyoscine is more effective in treating drooling in children with non-progressive neurodisability. The study will also determine which medications at what doses are most acceptable and have fewest side effects. This information will be used to develop evidence based guidance to inform the medical treatment of drooling. DRI TRIAL REGISTRATION: Current Controlled Trials: ISRCTN75287237.EUDRACT: 2013-000863-94.Medicines and Healthcare products Regulatory Agency (MHRA): 17136/0264/001-0003.


Subject(s)
Developmental Disabilities/complications , Glycopyrrolate/therapeutic use , Muscarinic Antagonists/therapeutic use , Nervous System Diseases/complications , Research Design , Salivation/drug effects , Scopolamine/therapeutic use , Sialorrhea/drug therapy , Adolescent , Child , Child, Preschool , Clinical Protocols , England , Glycopyrrolate/adverse effects , Humans , Muscarinic Antagonists/adverse effects , Patient Satisfaction , Scopolamine/adverse effects , Sialorrhea/diagnosis , Sialorrhea/etiology , Sialorrhea/physiopathology , Single-Blind Method , Surveys and Questionnaires , Time Factors , Treatment Outcome
2.
Paediatr Int Child Health ; 32(3): 158-60, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22824664

ABSTRACT

BACKGROUND: In 2010, there was a sudden increase in the number of children admitted to Okomfo Anokye Teaching Hospital, Kumasi with caustic soda poisoning. AIM: To quantify the increase and identify possible causes. METHODS: Detailed review of case-notes of all children admitted with poisoning from January 2009 to June 2010 was undertaken using a standardised proforma. RESULTS: From January to June 2010, there was a six-fold increase in the number of children admitted with caustic soda poisoning compared with January to June 2009 (13 vs 2). Owing to the increase in caustic soda ingestion, there were almost twice the number of cases of chemically-induced poisoning in January-June 2010 (34) as in January-June 2009 (19 cases). In the entire period (January 2009 to June 2010), the majority of admissions for chemical poisoning were children ≤3 years of age and 50 of the 72 (69.4%) cases were boys. In six of the 13 cases in the January-June 2010 period, caustic soda was drunk directly from a plastic water bottle. All children with caustic soda poisoning had been given palm oil to drink by their guardians. CONCLUSION: It is suggested that the recent introduction of bottled water is an important element in the increase of caustic soda poisoning. Previously, water was sold in plastic bags. The plastic water bottles are re-used to store caustic soda which children then drink, mistaking it for water.


Subject(s)
Poisoning/epidemiology , Sodium Hydroxide/toxicity , Accidents, Home/prevention & control , Accidents, Home/trends , Child , Child, Preschool , Female , Ghana/epidemiology , Humans , Infant , Male
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