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

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ClinicalTrials.gov Identifier: NCT03781817
Recruitment Status : Not yet recruiting
First Posted : December 20, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
James Statler, University of Alabama at Birmingham

Brief Summary:
This a randomized clinical trial involving children with non-operative fractures presenting the emergency department randomized either to intranasal or intravenous ketamine.

Condition or disease Intervention/treatment Phase
Trauma Fractures, Closed Children, Only Deep Sedation Ketamine Drug: Intravenous Ketamine Drug: Intranasal Ketamine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Intravenous ketamine
Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.
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.

Experimental: Intranasal ketamine
Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781817


Contacts
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Contact: James Statler, MD 205-638-6098 jstatler@uabmc.edu
Contact: Nipam Shah, MBBS, MPH 205-638-7431 nshah@peds.uab.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: James Statler, MD    205-638-6098    jstatler@uabmc.edu   
Contact: Nipam Shah, MBBS, MPH    205-638-7431    nshah@peds.uab.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: James Statler, MD University of Alabama at Birmingham

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Responsible Party: James Statler, Pediatric Emergency Medicine Fellow, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03781817     History of Changes
Other Study ID Numbers: IRB-300002731
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by James Statler, University of Alabama at Birmingham:
procedural sedation
ketamine
pediatric
fracture
intranasal
intravenous
emergency department

Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Closed
Wounds and Injuries
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action