Risperidone in children with autism and serious behavioral problems
Child; Female; Humans; Male; Treatment Outcome; Double-Blind Method; adolescent; Preschool; Non-U.S. Gov't; P.H.S.; Research Support; U.S. Gov't; Comparative Study; Antipsychotic Agents/administration & dosage/adverse effects/therapeutic use; Autistic Disorder/drug therapy/psychology; Child Behavior/drug effects; Risperidone/administration & dosage/adverse effects/therapeutic use
BACKGROUND: Atypical antipsychotic agents, which block postsynaptic dopamine and serotonin receptors, have advantages over traditional antipsychotic medications in the treatment of adults with schizophrenia and may be beneficial in children with autistic disorder who have serious behavioral disturbances. However, data on the safety and efficacy of atypical antipsychotic agents in children are limited. METHODS: We conducted a multisite, randomized, double-blind trial of risperidone as compared with placebo for the treatment of autistic disorder accompanied by severe tantrums, aggression, or self-injurious behavior in children 5 to 17 years old. The primary outcome measures were the score on the Irritability subscale of the Aberrant Behavior Checklist and the rating on the Clinical Global Impressions - Improvement (CGI-I) scale at eight weeks. RESULTS: A total of 101 children (82 boys and 19 girls; mean [+/-SD] age, 8.8+/-2.7 years) were randomly assigned to receive risperidone (49 children) or placebo (52). Treatment with risperidone for eight weeks (dose range, 0.5 to 3.5 mg per day) resulted in a 56.9 percent reduction in the Irritability score, as compared with a 14.1 percent decrease in the placebo group (P<0.001). The rate of a positive response, defined as at least a 25 percent decrease in the Irritability score and a rating of much improved or very much improved on the CGI-I scale, was 69 percent in the risperidone group (34 of 49 children had a positive response) and 12 percent in the placebo group (6 of 52, P<0.001). Risperidone therapy was associated with an average weight gain of 2.7+/-2.9 kg, as compared with 0.8+/-2.2 kg with placebo (P<0.001). Increased appetite, fatigue, drowsiness, dizziness, and drooling were more common in the risperidone group than in the placebo group (P<0.05 for each comparison). In two thirds of the children with a positive response to risperidone at eight weeks (23 of 34), the benefit was maintained at six months. CONCLUSIONS: Risperidone was effective and well tolerated for the treatment of tantrums, aggression, or self-injurious behavior in children with autistic disorder. The short period of this trial limits inferences about adverse effects such as tardive dyskinesia.
2002
McCracken JT; McGough J; Shah B; Cronin P; Hong D; Aman MG; Arnold LE; Lindsay R; Nash P; Hollway J; McDougle CJ; Posey D; Swiezy N; Kohn A; Scahill L; Martin A; Koenig K; Volkmar F; Carroll D; Lancor A; Tierney E; Ghuman J; Gonzalez NM; Grados M; Vitiello B; Ritz L; Davies M; Robinson J; McMahon D; Research Units on Pediatric Psychopharmacology (RUPP) Autism Network
The New England Journal Of Medicine
2002
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
Journal Article
<a href="http://doi.org/10.1056/NEJMoa013171" target="_blank" rel="noreferrer">10.1056/NEJMoa013171</a>
Adequacy Of Palliative Care In A Single Tertiary Neonatal Unit
End Of Life Care; Palliative Care; Death; Neonatal; Perinatal Death; Infant; Parents; End Of Life Care; Child; Palliative Care; Narcotics; Hospice Care; Pediatrics
Aim: End-of-life care remains within the scope of practice of all neonatal units. There is a paucity of literature regarding the evidence-base for palliative care interventions in the perinatal or neonatal population (Balaguer).
Little is published regarding neonatal end-of-life care in Australia (Wilkinson). This study aimed to characterise the end-of-life care provided in an Australian tertiary neonatal centre, where paediatric palliative care was accessible via a consultative service.
Methods: This retrospective cohort study examined indicators of quality palliative care provided to forty-six infants born within a thirty-month period from January 2012 to June 2014. Included infants were liveborn, admitted to the Royal Brisbane and Women's Hospital at some time in their life and died prior to one year of age. Infants were excluded if there was no opportunity for palliative care. Indicators of quality palliative care assessed included communication, resuscitation planning, preferred location of death, symptom management, symptom management plan, multi-disciplinary team approach, caring for carers, memory making, spiritual care and bereavement care. Interventions were characterised using descriptive statistics.
Results: The most common causes of death were congenital abnormality (37%) and complications of extreme prematurity (22%). Very high proportions of infants and families had family meetings (100%), social worker involvement (100%), memory making opportunities (100%) and discussion of autopsy (91%). Opiates were prescribed to 78% in the last day of life; most (89%) were administered intravenously. For those prescribed opiates, the median parenteral morphine daily equivalent was 290 mcg/kg/day (interquartile range = 317) in the last 24 hours of life. Antenatal resuscitation planning for fetuses with a prenatal diagnosis (9%), discussion of preferred location of death (9%), communication with general practitioners (7%) and access to specialised bereavement care (3%) were infrequently provided. Palliative care consultation was sought infrequently (n = 4; 8%), precluding formal statistical comparison with the usual neonatal care cohort. The relative number of instances where indicators of quality palliative care were met was generally greater when palliative care was consulted.
Conclusions: At the time of this study, the neonatal unit was not meeting all of the end-of-life care needs of infants and their families. Care was more comprehensive when the palliative care service was consulted.
Gilmour D; Davies M; Herbert A
Journal Of Paediatrics And Child Health
2016
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
<a href="https://onlinelibrary.wiley.com/doi/full/10.1111/jpc.13245_16">10.1111/jpc.13245_16</a>