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There is a wide variation of published IV ketamine dosing regimens used for procedural sedation in children in the Emergency Department (ED). The purpose of the study was to compare the efficacy, duration of sedation and adverse events between the three commonly administered doses of IV ketamine (1 mg/kg, 1.5 mg/kg and 2 mg/kg) using the traditional administration method of 30-60 second infusion for ED sedation in children.
This was a prospective, double-blind, randomized controlled trial of children aged 3 to 18 years who received IV ketamine for procedural sedation and analgesia (PSA) for orthopedic procedures, incision and drainage (I & D) of skin abscess and laceration repair in an inner city, tertiary care pediatric ED. Random sequence allocation was performed using a computer-generated, random number table by the study research pharmacist. The study participants were grouped according to their age as follows (1) 3-6 years (2) 7-12 years (3) 13-18 years. Children from each age group were assigned in equal numbers to all three ketamine dosing (1 mg/kg, 1.5 mg/kg and 2 mg/kg) groups using random permuted blocks stratified by the pharmacist. All ED staff including the physician and the nurse in charge of sedation, the study research assistant, the parents/guardians and the study subjects were blinded to the randomization and the group assignments. The dosage and administration of additional doses of ketamine were left to the discretion of the ED physician in charge of the sedation. The research team did not participate in the clinical care including sedation of the patient. Children were monitored per ED policy for the entire duration of sedation. Three 1 ml blood samples for the ketamine assay was collected from the existing intravenous access at three time intervals: 3-5 minutes after ketamine administration, at midpoint during the procedure and prior to discharge of the patient from the ED. In the event a second dose of ketamine was administered, a 4th 1 ml sample was collected 3-5 minutes after the 2nd dose in children weighing >20 kilograms. Patient demographics, procedure type, NPO status , ASA classification, pain medication administered prior to sedation (timing, dosage and type), number and total doses of ketamine administered after the initial study dose, sedation efficacy and duration, length of procedure, adverse events related to sedation, interventions performed to address the adverse events and patient disposition were collected. The study research assistant also performed a follow up phone call to the parents/caregivers of the children 48 hours after ED discharge to collect information on adverse events that happened at home . A total of 3 attempts were made to contact the parent/caregiver after which the participant was considered as lost to followup.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketamine IV 1 mg/kg | Experimental | Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients |
|
| Ketamine IV 1.5 mg/kg | Experimental | Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients |
|
| Ketamine IV 2 mg/kg | Experimental | Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine IV 1mg/kg | Drug | Intervention: Ketamine IV 1mg/kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation Efficacy | Measure sedation depth using Ramsay Sedation Scale. Varies from 1-6 with 1: anxious, agitated, restless 2: Cooperative, oriented, tranquil 3: responsive to commands 4: Brisk response to light glabellar tap or auditory stimulus 5: Sluggish response to light glabellar tap or loud auditory stimulus 6 being no response to light glabellar tap or loud auditory stimulus. Higher the score, greater is the depth of sedation. Use of ketamine usually provides a depth of sedation of 5 or 6. | Participants will be assessed after study drug adminsitration and the maximum depth of sedation achieved recorded. Approximately 2 hours |
| Pain | Measure pain using self reported Wong Baker faces pain rating scale prior to sedation, during sedation and prior to discharge.The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". The patient must choose the face that best describes how they are feeling. The score has values of 0(no hurt), 2(hurts little bit), 4(hurts little more), 6(hurts even more), 8(hurts whole lot),10 (hurts worst). The patient chooses one number that describes the pain best (eg. Either a 2 or 4). | Patients will be assessed during the procedure after administration of sedation medicaiton. Approximately 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation Duration | Length of sedation was defined as the time duration from the administration of study medication until ready for discharge using standardized discharge criteria (Aldrete scoring >9) followed at our institution. | Patients will be assessed during the length of time from administration of sedation medication until ready for discharge, Approximately 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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11 consented patients were excluded as sedation and procedure was performed in the operating room rather than in the Emergency Department
Conducted at a level 1 trauma Pediatric Emergency Department from July 1st 2010 to August 31st 2012. We enrolled a convenience sample of eligible patients. Study participants were identified using the electronic medical tracking board which lists the presenting complaint and after need for IV ketamine sedation was established with physician.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine IV 1 mg/kg | Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg |
| FG001 | Ketamine IV 1.5 mg/kg | Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg |
| FG002 | Ketamine IV 2 mg/kg | Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Children aged3-18 years who received procedural sedation and analgesia in the Emergency Department
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine IV 1 mg/kg | Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg |
| BG001 | Ketamine IV 1.5 mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sedation Efficacy | Measure sedation depth using Ramsay Sedation Scale. Varies from 1-6 with 1: anxious, agitated, restless 2: Cooperative, oriented, tranquil 3: responsive to commands 4: Brisk response to light glabellar tap or auditory stimulus 5: Sluggish response to light glabellar tap or loud auditory stimulus 6 being no response to light glabellar tap or loud auditory stimulus. Higher the score, greater is the depth of sedation. Use of ketamine usually provides a depth of sedation of 5 or 6. | Posted | Median | Inter-Quartile Range | units on a scale | Participants will be assessed after study drug adminsitration and the maximum depth of sedation achieved recorded. Approximately 2 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketamine IV 1 mg/kg | Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oxygen Desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Pulse oximetry <90% in room air |
Convenience sample of patients enrolled. One fourth of patients did not receive the dose that they were randomized to. We did not enroll children <3 years. We did not randomize by procedure type which could have confounded length of sedation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nirupama Kannikeswaran | Children's Hospital of Michigan | 313-745-5260 | nkannike@dmc.org |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Ketamine IV 1.5mg/kg |
| Drug |
Intervention: Ketamine IV 1.5 mg/kg |
|
| Ketamine IV 2mg/kg | Drug | Intervention: Ketamine IV 2 mg/kg |
|
| Additional Dose | Number of participants to whom additional doses of ketamine administered apart from the study dose | Patients will be assessed during procedure . Approximately 1 hours |
| Adverse Events | Adverse events secondary to sedation experienced by the patient and interventions performed to overcome them | Patients will be assessed after administration of medication until discharge and will have a follow up phone call 48 hours after discharge for 3 attempts. 5 days., |
| Sedation Satisfaction | Consultants will be asked to rate their level of satisfaction with sedation on a Likert Scale of 1-3 | At the end of the procedure. Approximately 1 hour |
Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg
| BG002 | Ketamine IV 2 mg/kg | Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| AMerican Society of Anesthesiologists (ASA) Category | The purpose of the ASA is to evaluate the degree of a patient's "sickness" or "physical state" before selecting the sedative or before performing the procedure. There are 6 categories
| Number | participants |
|
| Procedure Type | Number | participants |
|
| OG001 |
| Ketamine IV 1.5 mg/kg |
Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg |
| OG002 | Ketamine IV 2 mg/kg | Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg |
|
|
|
| Primary | Pain | Measure pain using self reported Wong Baker faces pain rating scale prior to sedation, during sedation and prior to discharge.The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". The patient must choose the face that best describes how they are feeling. The score has values of 0(no hurt), 2(hurts little bit), 4(hurts little more), 6(hurts even more), 8(hurts whole lot),10 (hurts worst). The patient chooses one number that describes the pain best (eg. Either a 2 or 4). | Posted | Median | Inter-Quartile Range | units on a scale | Patients will be assessed during the procedure after administration of sedation medicaiton. Approximately 30 minutes |
|
|
|
|
| Secondary | Sedation Duration | Length of sedation was defined as the time duration from the administration of study medication until ready for discharge using standardized discharge criteria (Aldrete scoring >9) followed at our institution. | Posted | Median | Inter-Quartile Range | Minutes | Patients will be assessed during the length of time from administration of sedation medication until ready for discharge, Approximately 3 hours |
|
|
|
|
| Secondary | Additional Dose | Number of participants to whom additional doses of ketamine administered apart from the study dose | Posted | Number | participants | Patients will be assessed during procedure . Approximately 1 hours |
|
|
|
| Secondary | Adverse Events | Adverse events secondary to sedation experienced by the patient and interventions performed to overcome them | Posted | Number | participants | Patients will be assessed after administration of medication until discharge and will have a follow up phone call 48 hours after discharge for 3 attempts. 5 days., |
|
|
|
|
| Secondary | Sedation Satisfaction | Consultants will be asked to rate their level of satisfaction with sedation on a Likert Scale of 1-3 | consultant satisfaction missing in 6 participants | Posted | Number | participants | At the end of the procedure. Approximately 1 hour |
|
|
|
|
| 0 |
| 50 |
| 5 |
| 50 |
| EG001 | Ketamine IV 1.5 mg/kg | Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg | 0 | 35 | 5 | 35 |
| EG002 | Ketamine IV 2 mg/kg | Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg | 0 | 40 | 4 | 40 |
|
| Emesis | Gastrointestinal disorders | Systematic Assessment | Vomiting during/post sedation |
|
| Unpleasant Recovery Reaction | Nervous system disorders | Systematic Assessment | agitation, hallucinations |
|
| Others | Skin and subcutaneous tissue disorders | Systematic Assessment | Rash |
|
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| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
|
| 0.5 |
| No |
| Superiority or Other |
| Title | Measurements |
|---|---|
|
| Very Satisfied |
|