Background <p>Suicidal ideation (SI) is a common reason for emergency department (ED) visits by adolescents. While intravenous (IV) ketamine rapidly reduces SI in adults, its efficacy in adolescents remains unstudied. We assessed the feasibility of a trial of a single dose IV ketamine to reduce adolescent SI in the ED.</p> Methods <p>This double-blind, randomized, placebo-controlled pilot trial was conducted from Jan-May 2024. Medically stable adolescents aged 12 to 17 years with moderate-to-severe SI were eligible. Participants were randomized to IV ketamine (0.5&#xa0;mg/kg; max 50&#xa0;mg) or IV normal saline (0.5&#xa0;ml/kg; max 50 mL), infused over 40&#xa0;min. They were monitored for 120&#xa0;min and then received usual ED mental health care. The primary outcome was trial feasibility (enrolment and follow-up success). The primary clinical outcome was SI severity at 40&#xa0;min post-infusion (T-40), measured using the Beck Scale for SI (SSI5), Montgomery-Asberg Depression Rating Scale item 10 (MADRS10) and Beck Depression Inventory item 9 (BDI9). Additional outcomes included hospital admission, adverse events, 30-day ED revisits and death.</p> Results <p>Twenty participants were eligible and were enrolled. All participants completed the infusion and day-1 follow-up; 90% completed day-7 follow-up. No serious adverse events occurred. While SI severity did not differ significantly between groups at T-40 (SSI5: <i>p</i> = 0.06; MADRS10: <i>p</i> = 0.19; BDI9: <i>p</i> = 0.18), fewer participants randomized to ketamine were hospitalized at the initial visit (risk difference 40%, 95%CI: 7, 69%).</p> Conclusions <p>Recruiting adolescents to an ED-based IV ketamine study for SI is feasible. A larger trial is needed to clarify potential clinical benefits.</p> Trial registration <p><a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> ID NCT06366334 (Registered 20240412).</p>

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Single dose IV ketamine for adolescent suicidal ideation in the emergency department: a pilot randomized trial

  • Michael Schlegelmilch,
  • Amy C. Plint,
  • Nicholas Barrowman,
  • Clare Gray,
  • Tyrus Crawford,
  • Stephen A. Kutcher,
  • Maala Bhatt

摘要

Background

Suicidal ideation (SI) is a common reason for emergency department (ED) visits by adolescents. While intravenous (IV) ketamine rapidly reduces SI in adults, its efficacy in adolescents remains unstudied. We assessed the feasibility of a trial of a single dose IV ketamine to reduce adolescent SI in the ED.

Methods

This double-blind, randomized, placebo-controlled pilot trial was conducted from Jan-May 2024. Medically stable adolescents aged 12 to 17 years with moderate-to-severe SI were eligible. Participants were randomized to IV ketamine (0.5 mg/kg; max 50 mg) or IV normal saline (0.5 ml/kg; max 50 mL), infused over 40 min. They were monitored for 120 min and then received usual ED mental health care. The primary outcome was trial feasibility (enrolment and follow-up success). The primary clinical outcome was SI severity at 40 min post-infusion (T-40), measured using the Beck Scale for SI (SSI5), Montgomery-Asberg Depression Rating Scale item 10 (MADRS10) and Beck Depression Inventory item 9 (BDI9). Additional outcomes included hospital admission, adverse events, 30-day ED revisits and death.

Results

Twenty participants were eligible and were enrolled. All participants completed the infusion and day-1 follow-up; 90% completed day-7 follow-up. No serious adverse events occurred. While SI severity did not differ significantly between groups at T-40 (SSI5: p = 0.06; MADRS10: p = 0.19; BDI9: p = 0.18), fewer participants randomized to ketamine were hospitalized at the initial visit (risk difference 40%, 95%CI: 7, 69%).

Conclusions

Recruiting adolescents to an ED-based IV ketamine study for SI is feasible. A larger trial is needed to clarify potential clinical benefits.

Trial registration

ClinicalTrials.gov ID NCT06366334 (Registered 20240412).