A pilot randomized trial of ketamine for suicidal ideation in a pediatric emergency department.
Yury Onikashvili, Heather Burt, Garth Meckler, Jeffrey N. Bone, Tatsuma Hind, Kendra Sih, Roberto Sassi, Karly Stillwell, Tyler Black, Quynh Doan
CJEM June 3, 2026 DOI: 10.1007/s43678-026-01190-7 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Pilot study Peer reviewed |
|---|---|
| Sample size | 15 |
| Population | Adolescents requiring hospitalization for suicidal ideation |
| Interventions | Ketamine Midazolam Saline |
| Dose | 0.5 mg/kg ketamine, 0.03 mg/kg midazolam |
| Duration | 90 minutes post-infusion for primary outcome; follow-up at 7, 14, 21, and 28 days |
| Topics | Esketamine Ketamine |
| Registration | NCT04955470 |
| Key findings | The trial design appeared feasible and safe, with a high participation rate (71%) and no serious adverse events. |
Abstract
ObjectivesEmergency department (ED) visits by adolescents with suicidal ideation have increased, with no rapid-acting treatments identified for ED use. This pilot study explored the feasibility of a randomized controlled trial of ketamine in the ED for adolescents with suicidal ideation.MethodsThree-arm, triple-blinded randomized controlled trial comparing intravenous ketamine (0.5 mg/kg), midazolam (0.03 mg/kg), and saline (0.9%) in adolescents requiring hospitalization for suicidal ideation. We primarily reported recruitment proportion as a measure of feasibility. Secondary outcomes included: additional aspects of feasibility (barriers to enrolment, retention, blinding, and adverse events) and distribution of suicidal ideation scores 90 min post-infusion on questions 3-5 of the Columbia Suicide Severity Rating Scale, item 10 of the Montgomery-Åsberg Depression Rating Scale, and a pragmatic 0-10 Likert scale to estimate future randomized controlled trial sample size.ResultsOut of 21 eligible patients and guardians, 15 (71%, 95% CI 48, 87%) agreed to participate when offered the opportunity. Key barriers to enrolment included limited ED resources and absence of a consenting parent at time of assessment. Retention at 7, 14, 21, and 28-days was 93, 86, 73, and 73%. No serious or unexpected adverse events occurred. Blinding appeared reasonably effective. The median [IQR] Columbia Suicide Severity Rating Scale, Montgomery-Åsberg Depression Rating Scale, and pragmatic Likert scale scores at 90 min were 0 [0, 2], 4 [2, 4], 5 [5, 6] for ketamine; 0 [0, 3], 3 [3, 6], 6 [3, 7] for midazolam; and 3 [2, 3], 4 [4, 5], 6 [6, 7] for saline.ConclusionsDespite a small sample, our participation rate was high and trial design appeared feasible and safe. Dedicated research nurses and a mature-minor consent process could address key barriers to enrolment in future trials to determine if ketamine could provide ED physicians with the first rapid-acting pharmacological treatment for acute pediatric suicidal ideation.Clinicaltrialsgov: NCT04955470.
Comparable studies
Other randomized controlled trials on ketamine, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Subanesthetic Effects of the Noncompetitive NMDA Antagonist, Ketamine, in Humans Healthy human subjects recruited from the community | 1994 | Randomized controlled trial | n = 19 |
| Antidepressant Efficacy of Ketamine in Treatment-Resistant Major Depression: A Two-Site Randomized Controlled Trial Patients with treatment-resistant major depression experiencing a major depressive episode | 2013 | Randomized controlled trial | n = 73 |
| Remifentanil-induced Postoperative Hyperalgesia and Its Prevention with Small-dose Ketamine Patients undergoing major abdominal surgery | 2005 | Randomized controlled trial | n = 75 |
| Efficacy of Intravenous Ketamine for Treatment of Chronic Posttraumatic Stress Disorder Patients with chronic PTSD related to a range of trauma exposures | 2014 | Randomized controlled trial | n = 41 |
| Ketamine-Induced Deficits in Auditory and Visual Context-Dependent Processing in Healthy Volunteers Healthy volunteers | 2000 | Single-blind placebo-controlled study | n = 20 |
Citations in the library
Cites 11
- The effect of a single dose of intravenous ketamine on suicidal ideation: a systematic review and individual participant data meta-analysis American Journal of Psychiatry October 3, 2017
- Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study American Journal of Psychiatry April 16, 2018
- Ketamine for rapid reduction of suicidal thoughts in major depression: a midazolam-controlled randomized clinical trial American Journal of Psychiatry December 5, 2017
- Esketamine Nasal Spray for Rapid Reduction of Depressive Symptoms in Patients With Major Depressive Disorder Who Have Active Suicide Ideation With Intent: Results of a Phase 3, Double-Blind, Randomized Study (ASPIRE II) The International Journal of Neuropsychopharmacology August 26, 2020
- Ketamine for rapid reduction of suicidal ideation: a randomized controlled trial Psychological Medicine August 12, 2015
and 6 more in the library