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

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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

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

Trial contacts and locations

1

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Central trial contact

Steven G Schauer, DO; Shawn M Varney, DO

Data sourced from clinicaltrials.gov

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