protocolSection identificationModule nctId: NCT06366334, orgStudyIdInfo id: 23/02E, briefTitle: Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation, acronym: KSI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Children's Hospital of Eastern Ontario, class: OTHER, descriptionModule briefSummary: Approximately 20% of Canadian adolescents experience thoughts of suicide, or suicidal ideation (SI), and suicide is the second leading cause of death among Canadians aged 15-19 years. The emergency department at CHEO sees approximately four patients per day with SI. Even though this is a medical emergency, there are no fast-acting treatments available.Ketamine is a medication that is commonly used to safely sedate children who require painful procedures in the emergency department. For nearly ten years, intravenous ketamine has also been shown to rapidly reduce SI in adults. However, ketamine as a treatment for SI has never been studied in adolescents. The primary study objective is to pilot a clinical trial that investigates intravenous ketamine to emergently treat SI in adolescents.If intravenous ketamine can relieve symptoms of SI for youth, this would have tremendous effects on patients and would dramatically change how physicians treat adolescent mental health emergencies. If ketamine is effective for several weeks, as it is in adults, it will help temporize patients until they receive more long-term psychiatric care. At the system level, it has the potential to reduce emergency visits and lengthy admissions. The investigators feel that the results of this study will be generalizable to pediatric centres across Canada and beyond., conditionsModule conditions: Suicidal Ideation, conditions: Suicidal Ideas, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Ketamine Hydrochloride, interventions name: Normal saline, outcomesModule primaryOutcomes measure: Proportion of eligible participants who complete the study protocol, secondaryOutcomes measure: Baseline distribution of responses to the first 5 questions of Beck Scale for Suicidal Ideation (SSI5), secondaryOutcomes measure: Baseline distribution of responses to the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10), secondaryOutcomes measure: Baseline distribution of responses to the suicide item (#9) from the Beck Depression Index (BDI9)., secondaryOutcomes measure: Baseline pragmatic assessment of the first 5 questions of the Beck Scale for Suicidal Ideation (SSI5), the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10), and the suicide item (#9) from the Beck Depression Index (BDI9)., secondaryOutcomes measure: Assessment of blinding, secondaryOutcomes measure: Treatment efficacy measured by the Beck Scale for Suicidal Ideation (SSI5), secondaryOutcomes measure: Treatment efficacy measured by the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10), secondaryOutcomes measure: Treatment efficacy measured by the suicide item (#9) from the Beck Depression Index (BDI9), secondaryOutcomes measure: Treatment durability measured by the Beck Scale for Suicidal Ideation (SSI5), secondaryOutcomes measure: Treatment durability measured by the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10), secondaryOutcomes measure: Treatment efficacy measured by the suicide item (#9) from the Beck Depression Index (BDI9), secondaryOutcomes measure: Admission to Hospital, secondaryOutcomes measure: Length of Stay in Hospital, secondaryOutcomes measure: ED revisits, otherOutcomes measure: Safety Outcome 1: Clinically significant tachycardia, otherOutcomes measure: Safety Outcome 2: Clinically significant hypertension, otherOutcomes measure: Safety Outcome 3: Vomiting, otherOutcomes measure: Safety Outcome 4: Dissociation, otherOutcomes measure: Safety Outcome 5: Death, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's Hospital Of Eastern Ontario, status: RECRUITING, city: Ottawa, state: Ontario, zip: K1H 8L1, country: Canada, contacts name: Maala Bhatt, MD, MSc., role: CONTACT, phone: 6137377600, phoneExt: 4178, email: mbhatt@cheo.on.ca, contacts name: Tyrus Crawford, role: CONTACT, phone: 6137377600, phoneExt: 4178, email: tcrawford@cheo.on.ca, geoPoint lat: 45.41117, lon: -75.69812, hasResults: False