Skip to content

Rapid Control of Agitation in violent Emergency department patients with Ketamine Vs Midazolam plus Haloperidol to help in asssessing and managing patients

Rapid Agitation Control with Ketamine Vs Midazolam Plus Haloperidol in the Emergency Medicine Department: An Exploratory Single Blinded Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/050150
Enrollment
70
Registered
2023-02-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: F54- Psychological and behavioral factors associated with disorders or diseases classified elsewhere

Interventions

Intervention1: ketamine: injection of 5mg/kg of ketamine in multiple syringes by intramuscular route(50 mg/ml
max.4ml per intramuscular site)once.After injection,RASS score will be recorded at every 5 mins interval until primary end point is reached .i.e.RASS less than or equal to -1 or until 30 mins of sedat

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age more than or equal to 18 years Patients with clinical diagnosis of severe agitation with Richmond Agitation Sedation Scale score of 3 or more

Exclusion criteria

Exclusion criteria: Attenders not willing to consent Pregnant females or breastfeeding females Patients with known allergy or hypersensitivity to drugs Known kidney or liver disease Known alcoholic disorder Contraindication to study medications

Design outcomes

Primary

MeasureTime frame
Time( in minutes) from study medication administration to adequate sedation defined RASS less than or equal to -1Timepoint: 30 minutes of sedation assessment period

Secondary

MeasureTime frame
Need for intubation Effect on acid-base gas analysis Effect on biochemical parameters Clinical outcomes Safety of study medications Need for rescue medicationsTimepoint: At every 5 mins interval for initial 30 mins then every 30 mins interval post drug administration till patient is in ED for need for intubation,safety of study medications,for rescue medications and for clinical outcomes.At baseline and at 30 mins for effect on acid base gas analysis and effect on biochemical parameters.

Countries

India

Contacts

Public ContactDr MAGISHA VARDHANI R

AIIMS Rishikesh

nidhi.em@aiimsrishikesh.edu.in9654871074

Outcome results

None listed

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