Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial (LDK-SI)

Brooke Army Medical Center

Status: Unknown

Conditions: Suicide

Treatments: Drug: Ketamine

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01892995

BAMC-385833-1

Details and patient eligibility

About

This study will enroll patients presenting to the emergency department with acute suicidal ideation meeting inclusion and exclusion criteria. Patients will be randomized to one of three arms: ketamine (intervention) or diphenhydramine (control) or placebo (control). Serial measurements will be made in the ED and at follow-up intervals.

Enrollment: 53 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients age 18 to less than 75 who present to the SAMMC ED with either overt or incidental suicidal ideations with a SADPERSONS score 5 or greater that the treating provider feels warrant formal evaluation.

Exclusion criteria

• -Poor vital sign stability hypoxia: O2 < 95%, hypotension: SBP< 90 hypertension: SBP>180 Heart rate: < 50 or >120 Respiratory Rate: <10 or >30
• Altered mental status or intoxication
• Patient is unwilling to participate or provide informed consent
• Any allergy to ketamine or diphenhydramine
• Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis
• Pregnancy or breast feeding
• Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis
• Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias
• Presence of intracranial mass or vascular lesion.
• Presence of a history of psychosis or hallucinations (as assessed by electronic chart review)
• Weight greater than 115 kg or less than 45kg
• History of increased intracranial pressure/hypertensive hydrocephalus
• Non-English speaking patients
• Patient is acutely psychotic
• Provider feels that patient currently or likely will require chemical and/or physical restraints
• History of prolonged QT-interval

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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53 participants in 3 patient groups, including a placebo group

Ketamine

Experimental group

Description:

active arm

Treatment:

Drug: Ketamine

Diphenhydramine

Sham Comparator group

Description:

sham arm

Treatment:

Drug: Ketamine

Saline

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Ketamine