Children, Only, Deep Sedation, Fractures, Closed, Ketamine, Trauma
Conditions
Keywords
procedural sedation, ketamine, pediatric, fracture, intranasal, intravenous, emergency department
Brief summary
This a randomized clinical trial involving children with non-operative fractures presenting the emergency department randomized either to intranasal or intravenous ketamine.
Detailed description
The purpose of this study is to determine if Intranasal Ketamine (INK) is efficacious for Procedural Sedation and Analgesia (PSA) when compared to Intravenous Ketamine (IVK) in children with non-operative fractures. The primary aim is to determine if INK provides non-inferior sedation to IVK as defined by a Modified Ramsay Sedation score of ≥ 4 and also to compare the proportion of successful procedure between two treatment groups. The secondary aim is to compare proportion of adverse events and compare duration of sedation and length of emergency department (ED) stay between treatment groups.
Interventions
Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
DRUGIntranasal Ketamine
Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children 1-18 years of age. * American Society of Anesthesiologists (ASA) I or II * Non-operative fracture requiring reduction * Body weight less than or equal to 25 kg as measured by standard weighing scale
Exclusion criteria
* ASA classification III or above * Age less than 1 year * History of hypertension, known coronary artery disease or Kawasaki disease, congestive heart failure, acute glaucoma or globe injury, increased intracranial pressure or intracranial mass lesion, acute porphyria, developmental delays, or major psychiatric disorder * Prior allergy to ketamine * Unavailable parent or guardian to provide consent * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Adequate Sedation. | Induction up to 10 minutes | Determine if IN ketamine provides non-inferior sedation to IV ketamine as defined by a Modified Ramsay Sedation score of ≥ 4. Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 4 or greater is set to be satisfactory for deep sedation. |
| Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications. | From induction to discharge from sedation by emergency physician, up to 3 hours. | Rescue medication is defined as requiring additional doses of Ketamine to maintain adequate sedation. Successful procedure completion will be define as completing the procedure with only the induction dose and without requiring rescue medications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Non-serious Adverse Events. | From induction to discharge from the emergency department. | Non-serious adverse events include allergic reaction, vomiting, emergence agitation, and oxygen desaturations. |
| Duration of Sedation Using Modified Ramsay Sedation Scale. | From induction to discharge from sedation by the emergency physician. | Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 2 or less is set to be satisfactory for discharge from sedation. |
| Duration of Emergency Department Stay. | From arrival to emergency department to discharge order entered by emergency physician. | Measured from time of arrival to emergency department to discharge order. |
Countries
United States
Participant flow
Recruitment details
Patient screening, enrollment and informed consent will be obtained in the emergency department (ED) of Children's of Alabama (COA). Data collection will take place in the ED as well as in Children's Park Place, Suite 110. The remainder of the research, including data analysis, and collaboration amongst the principal investigator and the sub-investigators, will be conducted in Children's Park Place, Suite 110.
Participants by arm
| Arm | Count |
|---|---|
| Intravenous Ketamine Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.
Intravenous Ketamine: Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved. | 17 |
| Intranasal Ketamine Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.
Intranasal Ketamine: Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved. | 23 |
| Total | 40 |
Baseline characteristics
| Characteristic | Intranasal Ketamine | Total | Intravenous Ketamine |
|---|---|---|---|
| Age, Continuous | 5 years STANDARD_DEVIATION 1.99 | 5 years STANDARD_DEVIATION 1.83 | 5 years STANDARD_DEVIATION 1.65 |
| Allergies No | 22 Participants | 39 Participants | 17 Participants |
| Allergies Yes | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 33 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Past Medical History No | 19 Participants | 35 Participants | 16 Participants |
| Past Medical History Yes | 4 Participants | 5 Participants | 1 Participants |
| Past Surgical History No | 20 Participants | 36 Participants | 16 Participants |
| Past Surgical History Yes | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 10 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 30 Participants | 14 Participants |
| Sex: Female, Male Female | 9 Participants | 16 Participants | 7 Participants |
| Sex: Female, Male Male | 14 Participants | 24 Participants | 10 Participants |
| Weight (kg) | 18.4 weight in kilograms STANDARD_DEVIATION 4.13 | 18.15 weight in kilograms STANDARD_DEVIATION 3.72 | 18.1 weight in kilograms STANDARD_DEVIATION 3.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 23 |
| other Total, other adverse events | 1 / 17 | 3 / 23 |
| serious Total, serious adverse events | 0 / 17 | 0 / 23 |
Outcome results
Primary
Number of Participants Who Achieved Adequate Sedation.
Determine if IN ketamine provides non-inferior sedation to IV ketamine as defined by a Modified Ramsay Sedation score of ≥ 4. Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 4 or greater is set to be satisfactory for deep sedation.
Time frame: Induction up to 10 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Ketamine | Number of Participants Who Achieved Adequate Sedation. | 17 Participants |
| Intranasal Ketamine | Number of Participants Who Achieved Adequate Sedation. | 4 Participants |
Primary
Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications.
Rescue medication is defined as requiring additional doses of Ketamine to maintain adequate sedation. Successful procedure completion will be define as completing the procedure with only the induction dose and without requiring rescue medications.
Time frame: From induction to discharge from sedation by emergency physician, up to 3 hours.
Population: Number of participants that required rescue dosing either due to inadequate sedation at 10 minutes or after adequate sedation at 10 minutes but requiring more sedation to complete the procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Ketamine | Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications. | 7 Participants |
| Intranasal Ketamine | Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications. | 22 Participants |
Secondary
Duration of Emergency Department Stay.
Measured from time of arrival to emergency department to discharge order.
Time frame: From arrival to emergency department to discharge order entered by emergency physician.
Population: Duration of total emergency department stay from arrival to the emergency department to discharge order entered by emergency physician.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine | Duration of Emergency Department Stay. | 325.65 Time (in minutes) | Standard Deviation 104.7 |
| Intranasal Ketamine | Duration of Emergency Department Stay. | 312.4 Time (in minutes) | Standard Deviation 67.7 |
Secondary
Duration of Sedation Using Modified Ramsay Sedation Scale.
Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 2 or less is set to be satisfactory for discharge from sedation.
Time frame: From induction to discharge from sedation by the emergency physician.
Population: Describes the duration of sedation (in minutes) from the start of induction to when participant was discharged from sedation by the emergency physician.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine | Duration of Sedation Using Modified Ramsay Sedation Scale. | 65.71 Minutes | Standard Deviation 32.54 |
| Intranasal Ketamine | Duration of Sedation Using Modified Ramsay Sedation Scale. | 101.21 Minutes | Standard Deviation 52.4 |
Secondary
Percentage of Participants With Non-serious Adverse Events.
Non-serious adverse events include allergic reaction, vomiting, emergence agitation, and oxygen desaturations.
Time frame: From induction to discharge from the emergency department.
Population: Percentage of participants that experienced any possible adverse events from sedation with either intravenous or intranasal ketamine.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intravenous Ketamine | Percentage of Participants With Non-serious Adverse Events. | Yes | 1 Participants |
| Intravenous Ketamine | Percentage of Participants With Non-serious Adverse Events. | No | 16 Participants |
| Intranasal Ketamine | Percentage of Participants With Non-serious Adverse Events. | Yes | 3 Participants |
| Intranasal Ketamine | Percentage of Participants With Non-serious Adverse Events. | No | 20 Participants |