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Comparasion of Midazolam, Lorazepam and Haloperidol-Promethazine combination for management of physically and verbally violent patients.

Comparative study of Intramuscular Midazolam, Lorazepam and Haloperidol-Promethazine combination for management of acute agitation. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070438
Enrollment
114
Registered
2024-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: F40-F48- Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders Health Condition 2: F10-F19- Mental and behavioral disorders due to psychoactive substance use Health Condition 3: F30-F39- Mood [affective] disorders Health Condition 4: F20-F29- Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders

Interventions

Intervention1: Midazolam: 5mg,Intramuscular injection, given once and repeated once, if required. Control Intervention1: Haloperidol plus Promethazine: 5mg haloperidol plus 50 mg promethazine ,Intramu

Sponsors

Government Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Altered Mental Status Scale (AMSS) score greater than 1

Exclusion criteria

Exclusion criteria: Patient with known allergy of either midazolam or lorazepam or haloperidol or promethazine. Patient with medically reversible cause of agitation (hypotension, hypoxia or hypoglycemia). Patient known to be pregnant or lactating. Patient presenting with drug withdrawals or drug intoxication within past 48 hours. Patient with history of head injury within past 48 hours. Patient in active Delirium. Patient chemically restrained in past 24 hours.

Design outcomes

Primary

MeasureTime frame
Time till adequate sedation using Altered Mental Status Scale (AMSS)Timepoint: 0 min, then every 3 minutes till adequate sedation

Secondary

MeasureTime frame
Need for repeat sedationTimepoint: 0,30 min, 1 hour, 6 hour, 12 hour

Countries

India

Contacts

Public ContactLakhwinder Singh

Government Medical College and Hospital, Sector 32, Chandigarh

drpritiarun@gmail.com9646121612

Outcome results

None listed

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