Low-dose intravenous ketamine with haloperidol in reducing delirium and agitation

Comparison of the effect of low-dose intravenous ketamine with haloperidol in reducing delirium and agitation in elderly patients admitted to the intensive care unit: an open-label randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230522058252N1

Enrollment

Registered

2023-05-27

Start date

2021-03-05

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Condition 1: Delirium in elderly patients. Condition 2: Agitation in elderly patients. Delirium, not induced by alcohol and other psychoactive substances Restlessness and agitation

Interventions

Intervention 1: Intervention group 1: receiving haloperidol 2.5 mg intramuscularly. Intervention 2: Intervention group 2: receiving ketamine at a dose of 20 mg.

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 65 years and hospitalization in the intensive care unit Richmond Agitation Sedation Score more equal to 2 Troponin and BNP not positive Systolic pressure less than 140 mm Hg Diastolic pressure less than 95 Heart rate less than 100

Exclusion criteria

Exclusion criteria: Dissatisfaction of the patient or the patient's guardian Cardiovascular disease History of psychosis

Design outcomes

Primary

Measure	Time frame
Reynolds and Richmond score less than one. Timepoint: At the beginning of the study (before the injection) and again at 5, 10, 15 minutes after the injection. Method of measurement: Reynolds and Richmond Score.	—

Secondary

Measure	Time frame
The duration of reaching a Reynolds and Richmond score less than one. Timepoint: At the beginning of the study (before the injection) and again at 5, 10, 15 minutes after the injection. Method of measurement: Reynolds and Richmond Score.;Side effects. Timepoint: 60 minutes after the start of the intervention. Method of measurement: ECG to evaluate QT interval, blood pressure, heart rate, presence of seizures or hallucinations before and after receiving any of the drugs.	—

Measure

Time frame

The duration of reaching a Reynolds and Richmond score less than one. Timepoint: At the beginning of the study (before the injection) and again at 5, 10, 15 minutes after the injection. Method of measurement: Reynolds and Richmond Score.;Side effects. Timepoint: 60 minutes after the start of the intervention. Method of measurement: ECG to evaluate QT interval, blood pressure, heart rate, presence of seizures or hallucinations before and after receiving any of the drugs.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Khalil Pestehei

Tehran University of Medical Sciences

khalilpesteh@yahoo.com+98 21 6658 1560

Outcome results

None listed

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