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There were challenges with recruitment in the ED due to ED staffing shortages and we were unable to meet the expected recruitment rate. The decision to stop study recruitment was solely due to operational and logistical limitations.
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Suicide is a leading cause of death for children and adolescents. Since warning signs of suicide and links to precipitating events differ between age groups, suicide can be difficult to predict. As a result, children often seek care for suicidal ideation (SI) in the emergency department (ED) where a limited number of treatment options exist. Current psychotherapies and pharmacotherapies, such as antidepressants, provide benefit over weeks or months and thus limits their effective application in the ED. Consequently, when there is an imminent threat to the child's safety, the typical management solution is to admit the patient to a safe environment and hopefully de-escalate over time. To address a more rapid-onset treatment option for SI, a number of studies in adults have suggested that a single, sub-anesthetic dose of intravenous ketamine can rapidly reduce depression and SI severity. These results are promising, but large-scale trials are needed to determine if ketamine is a safe and effective treatment for acute suicidality in the pediatric population. This approach has the benefit of working rapidly, avoiding involuntary hospitalizations, and protecting patients from self-harm until they can be connected to longer term mental health resources. This study will compare the use of intravenous ketamine to both active and placebo controls in children 10 to 17 years of age presenting to the pediatric ED for SI. The primary objective of this pilot trial is to explore the adequacy and range of three instruments measuring suicidality and to determine the sample size required for a large definitive randomized control trial. This larger trial will be used to estimate the effectiveness of intravenous ketamine for reducing SI in children in the pediatric ED. The secondary objectives are to assess study feasibility and optimize study procedures. Given very few side effects reported in adult studies and the relatively benign nature of those reported, the investigators do not expect any major safety concerns in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous ketamine | Experimental | Infusion of 0.5 mg/kg of ketamine, at maximum dose of 40 mg, over 40 minutes. |
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| Intravenous midazolam | Active Comparator | Infusion of 0.03 mg/kg of midazolam, at maximum dose of 2 mg, over 40 minutes. |
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| Intravenous saline | Placebo Comparator | Infusion of 0.9% saline over 40 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine Injectable Solution | Drug | A 10 mg/mL solution of ketamine will be infused over a 40 minute period at a dose of 0.05mg/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Columbia Suicide Severity Rating Scale (C-SSRS) | The CSSR-S is 6-point scale that measures SI severity via clinical interviews, ranging from 1 (wish to be dead) to 5 (suicidal intent with plan). Adolescents who deny any SI receive a 0. The distribution of "yes" responses on questions 3, 4, or 5 will be assessed from baseline. Higher scores indicate greater SI severity. | 90 minutes post infusion |
| Montgomery-Åsberg Depression Rating Scale (MADRS) | The MADRS is a 10-item, 6-point scale that screens for depressive symptoms in adults via clinical interviews. A self-reported version (MADRS-self assessment) which has been validated in adolescents will be used, but only the final item that is specific to SI (item 10) will be asked. The distribution of scores from 0 to 6 will be assessed from baseline. Higher scores indicate greater SI severity. | 90 minutes post infusion |
| Pragmatic questionnaire | The pragmatic questionnaire is a brief, one sentence question designed to assess change in SI. Participants will be asked "How suicidal do you feel on a scale of 0 to 10?". The distribution of scores from 0 to 10 will be assessed from baseline. Higher scores indicate greater SI severity. | 90 minutes post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Columbia Suicide Severity Rating Scale (C-SSRS) | The CSSR-S is 6-point scale that measures SI severity via clinical interviews, ranging from 1 (wish to be dead) to 5 (suicidal intent with plan). Adolescents who deny any SI receive a 0. The distribution of "yes" responses on questions 3, 4, or 5 will be assessed from baseline. Higher scores indicate greater SI severity. | 24 hours |
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The study will enroll children and adolescents presenting with SI in the paediatric ED.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quynh Doan, PhD MHSc MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Children's Hospital | Vancouver | British Columbia | V6H 3N1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42234079 | Derived | Onikashvili Y, Burt H, Meckler G, Bone JN, Hind T, Sih K, Sassi R, Stillwell K, Black T, Doan Q. A pilot randomized trial of ketamine for suicidal ideation in a pediatric emergency department. CJEM. 2026 Jun 3. doi: 10.1007/s43678-026-01190-7. Online ahead of print. |
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Midazolam Injectable Solution | Drug | A 5 mg/mL solution of midazolam will be infused over a 40 minute period at a dose of 0.02 mg/kg. |
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| Normal Saline 0.9% Injectable Solution | Drug | A 0.9% normal saline solution will be infused over a 40 minute period. |
|
| Montgomery-Åsberg Depression Rating Scale (MADRS) | The MADRS is a 10-item, 6-point scale that screens for depressive symptoms in adults via clinical interviews. A self-reported version (MADRS-self assessment) which has been validated in adolescents will be used, but only the final item that is specific to SI (item 10) will be asked. The distribution of scores from 0 to 6 will be assessed from baseline. Higher scores indicate greater SI severity. | 24 hours, 7-, 14-, 21-, and 28 days |
| Pragmatic questionnaire | The pragmatic questionnaire is a brief, one sentence question designed to assess change in SI. Participants will be asked "How suicidal do you feel on a scale of 0 to 10?". The distribution of scores from 0 to 10 will be assessed from baseline. Higher scores indicate greater SI severity. | 24 hours, 7-, 14-, 21-, and 28 days |
| Blinding assessment | The proportion of participants and research personnel that correctly identify treatment arm allocation. | 90 minutes post infusion |
| Enrolment rate | Proportion of eligible patients that consent to participate, and proportion of participants that are lost to follow-up at 7-, 14-, 21-, and 28-days. | 28-days |
| Demographics | Demographics of eligible patients who decline to participate in the study. | 28-days |
| Drug reactions | Incidence and frequency of side effects and adverse events. | 28-days |