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Agitation clinical trials

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NCT ID: NCT01501123 Completed - Agitation Clinical Trials

Pre-hospital Agitation and Sedation Trial: A Randomized Controlled Trial of Haloperidol Versus Midazolam for the Sedation of the Agitated Patient

PHAST
Start date: November 2011
Phase: N/A
Study type: Interventional

PREHOSPITAL AGITATION AND SEDATION TRIAL (PHAST) - The goal of the PHAST is to demine whether haloperidol is superior to midazolam for the sedation of agitated patients in the prehospital environment - The primary outcome is the time to a Richmond Agitation and Sedation Scale (RASS) ≤1 o The RASS is a well validated standardized score to measure a patient's agitation - The secondary outcomes are - Time until RASS returns to 0 or 1 if RASS <0 - Need for additional sedation - Adverse effects (need for intubation, arrhythmia) - Mercy EMS will be the only EMS agency in the Commonwealth of Pennsylvania carrying haloperidol - Identification of potential study patients will be per state protocols - Exclusion Criteria for the study - Age <18 - Pregnant - Allergic to study medication - Transport to hospital other than Mercy Fitzgerald Hospital - Unable to reach medical command prior to giving medication - When a paramedic identifies a possible study candidate, the paramedic will consult medical command to see if the patient is appropriate for the study - If the medical command agrees the patient is appropriate for the study, patients will be randomized to - Odd days: Haloperidol 5mg IM (age <65) or haloperidol 2.5 mg IM (age ≥65) - Even days: Midazolam 0.05 mg IM to maximum of 5mg IM (age <65) or maximum of 2.5mg (age ≥65) - The RASS will be documented by the prehospital providers every 5 minutes until arrival at the hospital - Once the patient arrives at the ED, the RASS will be documented in PICIS® by the emergency department nurse at the time of triage and at a minimum of hourly until the RASS =0 or 1 for 2 consecutive hours - Questions may be directed to Dr. Isenberg at disenberg@mercyhealth.org or at (267) 205-6453 Richmond Agitation Sedation Scale RASS RASS Description - 4 Combative, violent, danger to staff - 3 Pulls or removes tube(s) or catheters; aggressive - 2 Frequent non-purposeful movement - 1 Anxious, apprehensive, but not aggressive 0 Alert and calm - 1 Awakens to voice (eye opening/contact) >10 sec - 2 Light sedation, briefly awakens to voice (eye opening/contact) <10 sec - 3 Moderate sedation, movement or eye opening. No eye contact - 4 Deep sedation, no response to voice, but movement or eye opening to physical stimulation - 5 Unarousable, no response to voice or physical stimulation

NCT ID: NCT01440114 Completed - Agitation Clinical Trials

The Effect of Intravenous Fentanyl Prior the End of Surgery on Emergence Agitation in Paediatric Patients After General Anesthesia

Start date: March 2010
Phase: N/A
Study type: Interventional

The propose of this study is to determine the effect of intravenous fentanyl prior the end of surgery on the incidence and severity of EA in pediatric patient.

NCT ID: NCT01400113 Completed - Agitation Clinical Trials

Treating Acutely Agitated Patients With Asenapine Sublingual Tablets

Start date: April 2012
Phase: Phase 4
Study type: Interventional

Our proposal is to administer asenapine to patients who are clinically agitated and in need of immediate intervention. At present there are no controlled studies that we know of that explores the use of asenapine for this purpose. Establishing the utility of asenapine for this common clinical problem will support its use as an additional treatment option in acutely agitated patients.

NCT ID: NCT01329536 Completed - Alzheimer's Disease Clinical Trials

The Occurrence of the ApoE4 Allele in Agitated In-Patients With Late-Onset Alzheimer's Disease

Start date: December 2010
Phase: N/A
Study type: Observational

The purpose of this clinical research study is to determine if a specific genetic allele is involved with the development of agitation in patients with late-onset Alzheimer's Disease (AD). The study will compare the results of genetic testing between two groups: individuals with late-onset AD who show signs of agitation and individuals with late-onset AD who do not show signs of agitation.

NCT ID: NCT01280890 Completed - Dementia Clinical Trials

Person- Centred Care Among Nursing Home Patients With Dementia

Start date: February 2011
Phase: N/A
Study type: Interventional

Dementia is a common and devastating disease in the elderly. No cure exist and there is an increasing need for care. To improve knowledge on how to provide better care for the patients with dementia in nursing homes, the investigators will carry out a controlled trial using two forms of education and developmental interventions towards the nursing home care staff: a structured framework (VIPS) and dementia care mapping (DCM)to develop person-centred care in a 10 months randomised controlled study. In accordance with the knowledge found in the literature the investigators hypothesize that both VIPS framework and DCM will be more effective than a traditional educational program about dementia provided to the staff in nursing homes. The positive effects will be seen as reduced agitation in patients, less use of psychotropic drugs and improved quality of life. Using VIPS framework and DCM will also have a better effect on staffs' well-being than traditional education in dementia. The aim of the study is to confirm or reject these hypotheses.

NCT ID: NCT01217541 Completed - Dementia Clinical Trials

Collaboration Between Department of Old Age Psychiatry and Nursing Homes

SAM-AKS
Start date: September 2010
Phase: N/A
Study type: Interventional

Dementia is a serious health problem showing an increasing prevalence rate with increasing age. In Norway, about 80% of nursing home patients have dementia. The mean age of nursing home residents in Norway is around 84 years. Disruptive and agitated behaviour affect 30-50% of all individuals with dementia at some point in the course of the illness. In addition, they have a combination of physical and psychological diseases which necessitates a close collaboration between different specialities in medicine and Old Age psychiatry. In collaboration with the communalities, our Old Age psychiatry services want to provide a new approach to this challenge and validate it on patient and personnel level.

NCT ID: NCT01119638 Completed - Alzheimer's Disease Clinical Trials

Escitalopram Treatment for BPSD in Alzheimer's Disease in Comparison to Risperidone

EscBPSD
Start date: April 2008
Phase: Phase 4
Study type: Interventional

Behavioral and psychological symptoms of dementia (BPSD) are among the most distressing manifestations of dementia. Pharmacotherapy is frequently used and especially in institutional settings. Current guidelines recommend the use of second-generation antipsychotics (SGAs). Nonetheless, there are concerns regarding both their safety and effectiveness in patients with dementia. Inconclusive evidence support the use of other psychoactive agents such as SSRI antidepressants or cognitive enhancers. In two published studies citalopram was as efficacious as, but better tolerated than perphenazine or risperidone in patients with BPSD. Thus, with proven efficacy and a beneficial safety profile the evaluation of the use of escitalopram for BPSD is warranted.

NCT ID: NCT01021696 Completed - Pain Clinical Trials

Pain in Patients With Dementia and Behavioural Disturbances

Start date: November 2009
Phase: Phase 2/Phase 3
Study type: Interventional

In nursing homes (NHs) 80% of the patients have dementia, between 60%-80% exhibit behavioural disturbances (BPSD), and more than 60% have pain. Both pain and BPSD is more common in those with severe dementia. Since older persons with dementia have less communicative skills, suffer from more pain and exhibit more agitation, pain may be a contributing factor in these patients. More than 40% of patients with BPSD are treated with neuroleptics despite described side-effects. There is an urgent need to investigate the impact of individual pain management on BPSD in patients with dementia. It was hypothesized that - pain increase BPSD in patients with dementia - individual pain treatment decrease BPSD in patients with dementia

NCT ID: NCT00898807 Completed - Alzheimer's Disease Clinical Trials

Citalopram for Agitation in Alzheimer's Disease

CitAD
Start date: July 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation in Alzheimer's dementia.

NCT ID: NCT00866645 Completed - Agitation Clinical Trials

A Study To Evaluate The Efficacy And Safety Of Intramuscular Levosulpiride In Patients With Agitation Of Schizophrenia

Start date: February 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy and safety of Intramuscular Levosulpiride in the treatment of Chinese patients with Agitation Of Schizophrenia compared with Intramuscular Haloperidol by evaluating the change of PANSS-EC total scores at end of study (72 hours after first dosing) from baseline.