RESUMEN
INTRODUCTION: Acute severe behavioural disturbance (ASBD) is a condition seen with increasing frequency in emergency departments (EDs) in adults and young people. Despite the increasing number of presentations and significant associated risks to patients, families and caregivers, there is limited evidence to guide the most effective pharmacological management in children and adolescents. The aim of this study is to determine whether a single dose of intramuscular olanzapine is more effective than intramuscular droperidol at successfully sedating young people with ASBD requiring intramuscular sedation. METHODS AND ANALYSIS: This study is a multicentre, open-label, superiority randomised controlled trial. Young people aged between 9 and 17 years and 364 days presenting to an ED with ASBD who are deemed to require medication for behavioural containment will be recruited to the study. Participants will be randomised in a 1:1 allocation between a single weight-based dose of intramuscular olanzapine and intramuscular droperidol. The primary outcome is the proportion of participants who achieve successful sedation at 1-hour post randomisation without the need for additional sedation. Secondary outcomes will include assessing for adverse events, additional medications provided in the ED, further episodes of ASBD, length of stay in the ED and hospital and satisfaction with management.Effectiveness will be determined using an intention-to-treat analysis, with medication efficacy determined as part of the secondary outcomes using a per-protocol analysis. The primary outcome of successful sedation at 1 hour will be presented as a percentage within each treatment group, with comparisons presented as a risk difference with its 95% CIs. ETHICS AND DISSEMINATION: Ethics approval was received from the Royal Children's Hospital Human Research Ethics Committee (HREC/69948/RCHM-2021). This incorporated a waiver of informed consent for the study. The findings will be disseminated in a peer-reviewed journal and at academic conferences. TRIAL REGISTRATION NUMBER: ACTRN12621001238864.
Asunto(s)
Droperidol , Prunus persica , Adulto , Adolescente , Humanos , Niño , Recién Nacido , Droperidol/uso terapéutico , Olanzapina/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
INTRODUCTION: Acute severe behavioural disturbance (ASBD) is a condition seen with increasing frequency in emergency departments (EDs) in adults and young people. Despite the increasing number of presentations and significant associated risks to patients, families and caregivers, there is limited evidence to guide the most effective pharmacological management in children and adolescents. The aim of this study is to determine whether a single dose of oral olanzapine is more effective than a dose of oral diazepam at successfully sedating young people with ASBD. METHODS AND ANALYSIS: This study is a multicentre, open-label, superiority randomised controlled trial. Young people aged between 9 years and 17 years and 364 days presenting to an ED with ASBD who are deemed to require medication for behavioural containment will be recruited to the study. Participants will be randomised in a 1:1 allocation between a single weight-based dose of oral olanzapine and oral diazepam. The primary outcome is the proportion of participants who achieve successful sedation at 1-hour post randomisation without the need for additional sedation. Secondary outcomes will include assessing for adverse events, additional medications provided in the ED, further episodes of ASBD, length of stay in the ED and hospital and satisfaction with management.Effectiveness will be determined using an intention-to-treat analysis, with medication efficacy determined as part of the secondary outcomes using a per-protocol analysis. The primary outcome of successful sedation at 1 hour will be presented as a percentage within each treatment group, with comparisons presented as a risk difference with its 95% CIs. ETHICS AND DISSEMINATION: Ethics approval was received from the Royal Children's Hospital Human Research Ethics Committee (HREC/66478/RCHM-2020). This incorporated a waiver of informed consent for the study. The findings will be disseminated in a peer-reviewed journal and at academic conferences. TRIAL REGISTRATION NUMBER: ACTRN12621001236886.
Asunto(s)
Prunus persica , Adulto , Adolescente , Humanos , Niño , Recién Nacido , Olanzapina , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
OBJECTIVE: Major depressive disorder (MDD) is relatively common in adolescence, with far-reaching impacts. Current treatments frequently fail to alleviate depression severity for a substantial portion of adolescents. Repetitive transcranial magnetic stimulation (rTMS) may assist with this unmet clinical need. However, little is known about adverse events (AEs) experienced by adolescents receiving rTMS, subjective treatment experiences of adolescents and their parents, or treatment acceptability. METHODS: Fourteen adolescents (16.5 years ± 1.2; 71.4% female) with MDD received 20 sessions of either high-frequency (10 Hz; n = 7) left dorsolateral prefrontal cortex (DLPFC) or low-frequency (1 Hz; n = 7) right DLPFC rTMS. AEs were monitored at baseline and at weekly intervals via New York State Psychiatric Institute Side Effects Form for Children and Adolescents. Eight adolescents and nine parents participated in interviews regarding subjective treatment experience, analysed via content analysis. RESULTS: Drowsiness and lethargy were common AEs, reported by 92.3% of participants in week one. Number of AEs decreased throughout treatment course (after 5 treatments: M = 11.23, SD = 5.00; after 20 treatments: M = 8.92, SD = 5.95). Thirty-five AEs emerged during treatment, most commonly transient dizziness. Frequency, severity, and number of AEs reported were equivalent between treatment groups. Treatment adherence and satisfaction were high. Qualitative findings identified three themes relating to rTMS experience: Preparation and connection; Physical experience of treatment; and Perceived role of treatment. LIMITATIONS: Sample size was small, therefore findings are preliminary. CONCLUSIONS: rTMS was an acceptable treatment for adolescent MDD, from both adolescents' and parents' perspectives, and was safe and well-tolerated, as AE frequency and type did not differ from rTMS treatment courses in adults.
Asunto(s)
Trastorno Depresivo Mayor , Estimulación Magnética Transcraneal , Adolescente , Adulto , Antidepresivos/uso terapéutico , Niño , Trastorno Depresivo Mayor/tratamiento farmacológico , Femenino , Humanos , Masculino , Corteza Prefrontal/fisiología , Estimulación Magnética Transcraneal/efectos adversos , Estimulación Magnética Transcraneal/métodos , Resultado del TratamientoRESUMEN
Initial evidence suggests that exercise is an effective method in reducing symptoms of depression amongst adolescents. It is important to examine clinician attitudes and practices regarding the incorporation of exercise in mental health treatment, and to examine potential facilitators and barriers to exercise prescription. An online survey was conducted amongst mental health clinicians (N = 125) working in the treatment of adolescent depression. Clinicians held favourable attitudes towards exercise, most frequently ranking exercise as the second most important treatment for adolescent depression following cognitive behaviour therapy. The majority of clinicians were found to prescribe exercise "always" (24.3%) or "most of the time" (43.4%). Significant positive relationships were found between confidence to prescribe exercise and knowledge surrounding exercise prescription and clinician exercise prescription rates, however no significant relationship was identified between clinician levels of exercise and exercise prescription. The most frequently endorsed barriers to exercise prescription included the belief that exercise prescription should be implemented by an exercise professional, a lack of knowledge surrounding exercise prescription for adolescent depression, and the belief that depressed adolescents will not adhere to an exercise program. Overall, clinicians held positive attitudes towards exercise in the treatment of adolescent depression, and often recommended exercise as part of treatment.