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A CLINICAL STUDY TO ASSESS THE EFFECTS OF TWO DRUGS, HALPERIDOL AND OLANZAPINE, IN ANXIOUS AND PHYSICALLY RESTLESS PATIENTS COMING TO EMERGENCY DEPARTMENT.

EFFICACY AND SAFETY OF INTRAMUSCULAR HALOPERIDOL AND OLANZAPINE IN MANAGEMENT OF ACUTELY AGITATED PATIENTS IN THE EMERGENCY DEPARTMENT: A RANDOMISED CONTROLLED TRIAL.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/030895
Enrollment
104
Registered
2021-02-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R451- Restlessness and agitation

Interventions

Intervention1: Olanzapine: 10 Mg Intramuscular single stat dose (1 more similar dose maybe repeated as rescue medication if adequate sedation is not achieved following single dose) Control Interventio

Sponsors

Department of emergency medicine All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Males and females between age of 18 and 65 years presenting to emergency department with agitation. Agitation being defined as psychomotor agitation or violent behavior assessed with Altered Mental Status Scale (AMSS) score of 3 or more.

Exclusion criteria

Exclusion criteria: 1.Patients with age less than 18 years. 2.Patients with age more than 65 years. 3.Pregnant or breast-feeding patients. 4.Known Hypersensitivity/allergy to given drugs. 5.Patients having known extrapyramidal symptoms or parkinsonism. 6.Individuals having pre-existing cardiovascular illness (CAD/ Previous h/o cardiac arrest/ sustained arrhythmias/ Family history of sudden cardiac death). 7.Individuals having pre-existing respiratory illness (Asthma or COPD). 8.Individuals with known pre-existing CVA or intracranial lesion. 9.Individuals having seizure disorder. 10.Individuals/LAR who fail to give valid consent. 11.Patients with known QTc prolongation.

Design outcomes

Primary

MeasureTime frame
Compare IM haloperidol to IM olanzapine in terms of proportion of patients adequately sedated , defined with Altered Mental Status Scale score of 0 or less.Timepoint: 15 mins—

Secondary

MeasureTime frame
Need for rescue medicationsTimepoint: If adequate sedation is not achieved by study medications and the clinician feel the need for administering additional medications for calming the patient.;Safety in terms of intubation/hypotension/arrhythmia/QTc prolongation/extrapyramidal side effects.Timepoint: Patients will be observed for above adverse affects for 12 hours or till he/she is discharged/admitted into respective departments (whichever is earlier)—

Countries

India

Contacts

Public ContactDr Yatharth Choudhary

All India Institute of Medical Sciences, New Delhi

jamshednayer@gmail.com9990345682

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026