Intravenous ketamine for emergency department treatment of suicidal ideation in a paediatric population: protocol for a double-blind, randomised, placebo-controlled, parallel-arm pilot trial (KSI study).
Michael Schlegelmilch, Amy C. Plint, Nicholas Barrowman, Clare Gray, Maala Bhatt
BMJ Open July 5, 2024 DOI: 10.1136/bmjopen-2024-085681 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Placebo-controlled Double-blind Pilot study Peer reviewed |
|---|---|
| Sample size | 20 |
| Population | Adolescents in a pediatric emergency department with suicidal ideation |
| Intervention | Ketamine |
| Dose | 0.5 mg/kg (max 50 mg) |
| Duration | 40-minute infusion, with follow-up at 40 min, 80 min, 120 min, 24 hours, and 7 days |
| Topics | Esketamine Ketamine |
| Keywords | Emergency service, hospital Paediatrics Suicide & self-harm Pediatric mental health Suicide prevention Emergency medicine Ketamine therapy Crisis intervention |
| Citations | 2 |
| Registration | NCT05468840 |
| Key findings | The feasibility of a trial of intravenous ketamine to reduce suicidal ideation in a pediatric emergency department will be assessed by the proportion of eligible patients who complete the study protocol. |
Abstract
Suicidal ideation (SI) is a common and severe cause of morbidity in adolescents. Patients frequently present to the emergency department (ED) for care, yet there is no acute therapeutic intervention for SI. A single dose of intravenous ketamine has demonstrated efficacy in rapidly reducing SI in adults; however, ketamine has not been studied in paediatrics. We aim to determine the feasibility of a trial of a single intravenous ketamine dose to reduce SI for patients in the paediatric ED. This will be a single-centre, double-blind, randomised, placebo-controlled, parallel-arm pilot trial of intravenous ketamine for ED treatment of SI in a paediatric population. one intravenous dose of 0.5 mg/kg of ketamine (max 50 mg), over 40 min. Placebo: one intravenous dose of 0.5 mL/kg (max 50 mL) of normal saline, over 40 min. Participants will be randomised in a 1:1 ratio. SI severity will be measured at baseline, 40 min, 80 min, 120 min, 24 hours and 7 days. We aim to recruit 20 participants. The primary feasibility outcome is the proportion of eligible patients who complete the study protocol. We will pilot three SI severity tools and explore the efficacy, safety and tolerability of the intervention. This study will be conducted according to Canadian Biomedical Research Tutorial, international standards of Good Clinical Practice and the Health Canada, Food and Drug Act, Part C, Division 5. The study documents have been approved by the CHEO Research Institute Research Ethics Board (CHEO REB (23/02E)). Participants must provide free and informed consent to participate. If incapable due to age, assenting participants with parental/legal guardian consent may participate. On completion, we will endeavour to present results at international conferences, and publish the results in a peer-reviewed journal. Participants will receive a results letter. NCT05468840.
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
Cited by 2
Cites 7
- Measurement of dissociative states with the Clinician‐Administered Dissociative States Scale (CADSS) Journal of Traumatic Stress 1998
- 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
- Ketamine for the acute treatment of severe suicidal ideation: double blind, randomised placebo controlled trial British medical journal February 2, 2022
- Efficacy of Intravenous Ketamine in Adolescent Treatment-Resistant Depression: A Randomized Midazolam-Controlled Trial. American Journal of Psychiatry March 3, 2021
- A simplified 6-Item clinician administered dissociative symptom scale (CADSS-6) for monitoring dissociative effects of sub-anesthetic ketamine infusions. Journal of Affective Disorders December 29, 2020
and 2 more in the library