Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03781817
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
James Statler, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE December 18, 2018
First Posted Date  ICMJE December 20, 2018
Last Update Posted Date September 18, 2019
Actual Study Start Date  ICMJE September 9, 2019
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
  • Achieved adequate sedation as evidenced by Modified Ramsay Sedation score. [ Time Frame: Induction up to 5 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.
  • Achieved adequate sedation as evidenced by Modified Ramsay Sedation score. [ Time Frame: From 5 minutes 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.
  • Achieved adequate sedation as evidenced by Modified Ramsay Sedation score. [ Time Frame: From 10 minutes to 15 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. [ Time Frame: From induction to 60 minutes. ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03781817 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
  • Proportions of patients with non-serious adverse events. [ Time Frame: From induction to 6 hours. ]
    Non-serious adverse events include allergic reaction, vomiting, emergence agitation, and oxygen desaturations.
  • Duration of sedation using Modified Ramsay Sedation scale. [ Time Frame: From induction to 6 hours. ]
    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. [ Time Frame: From arrival to emergency department to 6 hours. ]
    Measured from time of arrival to emergency department to discharge order.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
Official Title  ICMJE Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Trauma
  • Fractures, Closed
  • Children, Only
  • Deep Sedation
  • Ketamine
Intervention  ICMJE
  • Drug: 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.
  • Drug: 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.
Study Arms  ICMJE
  • Active Comparator: Intravenous ketamine
    Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.
    Intervention: Drug: Intravenous Ketamine
  • Experimental: Intranasal ketamine
    Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.
    Intervention: Drug: Intranasal Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2019)
70
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2018)
66
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: James Statler, MD 205-638-6098 jstatler@uabmc.edu
Contact: Nipam Shah, MBBS, MPH 205-638-7431 nshah@peds.uab.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03781817
Other Study ID Numbers  ICMJE IRB-300002731
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party James Statler, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Statler, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP