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Objectives <p>Emergency 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.</p> Methods <p>Three-arm, triple-blinded randomized controlled trial comparing intravenous ketamine (0.5&#xa0;mg/kg), midazolam (0.03&#xa0;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&#xa0;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.</p> Results <p>Out 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&#xa0;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.</p> Conclusions <p>Despite 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.</p> <p>ClinicalTrials.gov: NCT04955470.</p>

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A pilot randomized trial of ketamine for suicidal ideation in a pediatric emergency department

  • 期刊论文

  • 发表日期：

    2026年6月3日

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  • Yury Onikashvili,
  • Heather Burt,
  • Garth Meckler,
  • Jeffrey N. Bone,
  • Tatsuma Hind,
  • Kendra Sih,
  • Roberto Sassi,
  • Karly Stillwell,
  • Tyler Black,
  • Quynh Doan

摘要

Objectives

Emergency 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.

Methods

Three-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.

Results

Out 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.

Conclusions

Despite 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.

ClinicalTrials.gov: NCT04955470.