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

A pilot trial tested the feasibility of a randomized controlled trial comparing intravenous ketamine (0.5 mg/kg), midazolam (0.03 mg/kg), and saline in adolescents hospitalized for suicidal ideation in the emergency department. Of 21 eligible patients, 15 (71%) agreed to participate. Key barriers to enrollment were limited ED resources and lack of a consenting parent. Retention at 7, 14, 21, and 28 days ranged from 93% to 73%. No serious adverse events occurred. Suicidal ideation scores 90 minutes after infusion were lower in the ketamine and midazolam groups than in the saline group, but the sample was too small for definitive conclusions. The trial design appeared feasible and safe.

Study at a glance

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.