Back to resultsIntranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
Primary Purpose
Trauma, Fractures, Closed, Children, Only
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intravenous Ketamine
Intranasal Ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Trauma focused on measuring procedural sedation, ketamine, pediatric, fracture, intranasal, intravenous, emergency department
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Intravenous ketamine
Intranasal ketamine
Arm Description
Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.
Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Percentage of Participants With Non-serious Adverse Events.
Non-serious adverse events include allergic reaction, vomiting, emergence agitation, and oxygen desaturations.
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.
Duration of Emergency Department Stay.
Measured from time of arrival to emergency department to discharge order.
Full Information
NCT ID
NCT03781817
First Posted
December 18, 2018
Last Updated
April 19, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT03781817
Brief Title
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
Official Title
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Transition/change of primary investigators
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
January 21, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Fractures, Closed, Children, Only, Deep Sedation, Ketamine
Keywords
procedural sedation, ketamine, pediatric, fracture, intranasal, intravenous, emergency department
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous ketamine
Arm Type
Active Comparator
Arm Description
Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.
Arm Title
Intranasal ketamine
Arm Type
Experimental
Arm Description
Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.
Intervention Type
Drug
Intervention Name(s)
Intravenous Ketamine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intranasal Ketamine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Achieved Adequate Sedation.
Description
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
Title
Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications.
Description
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.
Secondary Outcome Measure Information:
Title
Percentage of Participants With Non-serious Adverse Events.
Description
Non-serious adverse events include allergic reaction, vomiting, emergence agitation, and oxygen desaturations.
Time Frame
From induction to discharge from the emergency department.
Title
Duration of Sedation Using Modified Ramsay Sedation Scale.
Description
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.
Title
Duration of Emergency Department Stay.
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Statler, MD
Organizational Affiliation
Emory University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Judson Barber, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
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