Four Interventions in the Management of Psychomotor Agitation, Safety and Efficacy Evaluation - Full Text View

Purpose

This study aims to evaluate the efficacy and safety of four options of medications in the management of acute psychomotor agitation,or violence and aggression situations in health services. All of the treatment options are already approved and currently used for this purpose. The options are: haloperidol plus midazolam, haloperidol plus promethazine, olanzapine and ziprasidone. The investigators hypothesized that all treatment options are effective in the treatment of acute agitation, but the combination haloperidol plus promethazine could elicit more adverse affects than the others.

Condition	Intervention
Psychomotor Agitation	Drug: haloperidol+promethazine Drug: haloperidol + midazolam Drug: olanzapine Drug: Ziprasidone

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Safety and Efficacy of Four Intramuscular Interventions for the Management of Acute Psychomotor Agitation

Resource links provided by NLM:

Drug Information available for: Haloperidol Promethazine hydrochloride Diphenhydramine Promethazine Diphenhydramine hydrochloride Midazolam hydrochloride Haloperidol decanoate Diphenhydramine citrate Ziprasidone hydrochloride Olanzapine Ziprasidone Ziprasidone mesylate Olanzapine pamoate

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

Reduction in the agitation score [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
Agitation scores were evaluated through two previously validated specific scales: ACES ( Agitation Calmness Evaluating Scale) and PANSS-EC ( Positive and Negative Symptoms Scale- Excited Component). The measure was collected by a blind rater at baseline and the subsequent measures aimed to evaluate the drug effect over agitation scores.

Secondary Outcome Measures:

Adverse effects [ Time Frame: 12,24 hours after baseline ] [ Designated as safety issue: Yes ]
Aiming to evaluate the occurrence of adverse effects in the 24 hours period of observation after administrating the first injection (Baseline), an exert from the UKU scale (Ugvalg klinisk Undersgelser Side Effect Scale )was applied by a blind rater, to evaluate the presence and intensity of possible side effects.

Enrollment:	120
Study Start Date:	February 2009
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: ziprasidone injection ziprasidone injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of the observation	Drug: Ziprasidone ziprasidone, 10 mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes period of observation
Active Comparator: haloperidol + midazolam, injection Haloperidol plus midazolam injection, after baseline measures of agitation,allowed to be repeated twice over the 90 minutes period of observation	Drug: haloperidol + midazolam haloperidol, 2,5mg plus midazolam, 7,5 mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes period of observation
Active Comparator: haloperidol + promethazine, injection haloperidol + promethazine injection after baseline measures of agitation, could be repeated after 30 minutes, and once more, if necessary, in the 90 minutes period of observation	Drug: haloperidol+promethazine haloperidol, 2,5mg plus promethazine,25mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, in the 90 minutes period of observation
Active Comparator: olanzapine, injection olanzapine, 10mg, intramuscular injection after baseline measures of agitation, could be repeated twice if necessary, between the 90 minutes of observation	Drug: olanzapine olanzapine, 10mg, intramuscular injection, after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of observation

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients featuring psychomotor agitation, with clinical need for intramuscular injection

Exclusion Criteria:

delirium, severe or unstable general medical condition, previous history of severe adverse effects with one of the treatment options

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485692

Locations

Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto, USP
Ribeirão Preto, São Paulo, Brazil, 14048-900

Sponsors and Collaborators

University of Sao Paulo

Investigators

Principal Investigator:

Celia Mantovani, MD

University of Sao Paulo

More Information

No publications provided

Responsible Party:	Celia Mantovani, Principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT01485692 History of Changes
Other Study ID Numbers:	UE0001
Study First Received:	November 28, 2011
Last Updated:	December 1, 2011
Health Authority:	Brazil: Ethics Committee Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:

Violence
Aggression
Psychiatric emergencies
Psychomotor agitation
Violent patient

Additional relevant MeSH terms:

Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Promethazine
Diphenhydramine
Midazolam
Haloperidol
Olanzapine
Ziprasidone
Haloperidol decanoate
Antipruritics

Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 22, 2013