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)
Introduction 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 reduc...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2024-07-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/7/e085681.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850197374788435968 |
|---|---|
| author | Amy C Plint Maala Bhatt Nicholas Barrowman Michael Schlegelmilch Clare Gray |
| author_facet | Amy C Plint Maala Bhatt Nicholas Barrowman Michael Schlegelmilch Clare Gray |
| author_sort | Amy C Plint |
| collection | DOAJ |
| description | Introduction 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.Methods and analysis 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. Intervention: 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.Ethics and dissemination 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.Trial registration number NCT05468840. |
| format | Article |
| id | doaj-art-0ed070afe5b84e8e83fa4e133d4d4767 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-0ed070afe5b84e8e83fa4e133d4d47672025-08-20T02:13:11ZengBMJ Publishing GroupBMJ Open2044-60552024-07-0114710.1136/bmjopen-2024-085681Intravenous 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)Amy C Plint0Maala Bhatt1Nicholas Barrowman2Michael Schlegelmilch3Clare Gray42 Department of Pediatrics, CHEO, Ottawa, Ontario, Canada2 Department of Pediatrics, CHEO, Ottawa, Ontario, Canada3 CHEO Research Institute, Ottawa, Ontario, Canada1 Pediatrics, Alberta Children`s Hospital, Calgary, Alberta, Canada4 Department of Psychiatry, CHEO, Ottawa, Ontario, CanadaIntroduction 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.Methods and analysis 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. Intervention: 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.Ethics and dissemination 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.Trial registration number NCT05468840.https://bmjopen.bmj.com/content/14/7/e085681.full |
| spellingShingle | Amy C Plint Maala Bhatt Nicholas Barrowman Michael Schlegelmilch Clare Gray 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) BMJ Open |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/14/7/e085681.full |
| work_keys_str_mv | AT amycplint intravenousketamineforemergencydepartmenttreatmentofsuicidalideationinapaediatricpopulationprotocolforadoubleblindrandomisedplacebocontrolledparallelarmpilottrialksistudy AT maalabhatt intravenousketamineforemergencydepartmenttreatmentofsuicidalideationinapaediatricpopulationprotocolforadoubleblindrandomisedplacebocontrolledparallelarmpilottrialksistudy AT nicholasbarrowman intravenousketamineforemergencydepartmenttreatmentofsuicidalideationinapaediatricpopulationprotocolforadoubleblindrandomisedplacebocontrolledparallelarmpilottrialksistudy AT michaelschlegelmilch intravenousketamineforemergencydepartmenttreatmentofsuicidalideationinapaediatricpopulationprotocolforadoubleblindrandomisedplacebocontrolledparallelarmpilottrialksistudy AT claregray intravenousketamineforemergencydepartmenttreatmentofsuicidalideationinapaediatricpopulationprotocolforadoubleblindrandomisedplacebocontrolledparallelarmpilottrialksistudy |