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Ketamine Pilot Study

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ClinicalTrials.gov Identifier: NCT05379179
Recruitment Status : Enrolling by invitation
First Posted : May 18, 2022
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
Meghan Spyres, University of Arizona

Tracking Information
First Submitted Date  ICMJE April 15, 2022
First Posted Date  ICMJE May 18, 2022
Last Update Posted Date September 13, 2022
Actual Study Start Date  ICMJE June 20, 2022
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2022)
Change in Pain assessment post medication [ Time Frame: 30-120 minutes after drug administration ]
Pain will be assessed using a numerical rating scale (0-10, with 0 being no pain and 10 being the worst pain) at 30, 60, and 120 minutes after medication administration.
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2022)
Pain assessment post medication [ Time Frame: 30-120 minutes after drug administration ]
Pain will be assessed using a numerical rating scale (0-10, with 0 being no pain and 10 being the worst pain) at 30, 60, and 120 minutes after medication administration.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2022)
Adverse Events [ Time Frame: During hospitalization, up to 120 minutes ]
A subjects chart will be reviewed to determine whether rescue medication was needed or if there were any adverse medications effects
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 Ketamine Pilot Study
Official Title  ICMJE Pilot Study: Ketamine for Acute Pain After Rattlesnake Envenomation
Brief Summary This is a pilot study to evaluate pain responses from two different approved medications (ketamine and fentanyl) in the treatment of pain after rattlesnake envenomation (RSE). Both medications are currently used in standard practice to treat both acute and chronic pain and are options for pain management after RSE. Multiple studies exist showing ketamine to be both safe and effective for the treatment of acute pain, and to be as good as or better than opioids for this indication. The specific comparison of ketamine to fentanyl, however, has never been studied for the treatment of acute pain after rattlesnake envenomation in the United States. The investigators plan to measure pain scores after a single dose of ketamine or fentanyl in patients shortly after being envenomated, followed by continued treatment of pain guided by the treating doctor. There will be no restrictions on additional pain medications given and no other changes to the treatment of these patients during their hospitalization. This research is important because pain after RSE can be difficult to control and may require frequent, high doses of opioids for several days. An effective non-opioid medication would be helpful both to better-control pain and to reduce exposure to opioids in this patient population. This study will compare patient-reported pain scores after receiving a single dose of ketamine or fentanyl in patients with rattlesnake bites who have been admitted to the toxicology service at Banner - University Medical Center Phoenix (BUMCP).
Detailed Description Multiple studies have shown ketamine to be safe and effective agent for acute pain syndromes. RSEs classically result in severe pain that can be difficult to control, despite use of opioids, non-opioid analgesics, and positioning techniques, including splinting and elevation. Furthermore, the ongoing opioid epidemic pushes clinicians to explore non-opioid agents to avoid unnecessary exposure of patients to these high-risk medications. At least one small study has shown ketamine to be safe in rattlesnake envenomated patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Following enrollment, subject will be randomly assigned to receive either ketamine, or fentanyl. A randomization masterlist has been developed that will be used to assign drug. Subjects will be assigned in sequential order. Each block will alternate between each drug. Subjects will have 50/50 chance of being assigned to ketamine or fentanyl.
Masking: Single (Participant)
Masking Description:
The blinding of the subjects is done by the investigators which is the block randomization; each block will alternate between each drug ketamine or fentanyl. Subject will not be told which pain medication they will receive.
Primary Purpose: Treatment
Condition  ICMJE Rattlesnake Envenomation
Intervention  ICMJE
  • Drug: Ketamine
    This study will compare patient-reported pain scores after receiving either ketamine or fentanyl for the treatment of acute pain due to a rattlesnake bite.
  • Drug: Fentanyl
    This study will compare patient-reported pain scores after receiving either ketamine or fentanyl for the treatment of acute pain due to a rattlesnake bite.
Study Arms  ICMJE
  • Active Comparator: Fentanyl

    Drug administration: A single dose of fentanyl 1mcg/kg IV, maximum 100 mcg, over 15 minutes.

    Time drug given will be documented Data obtained prior to med administration and then following medication administration at intervals of 15, 30, 60 and 120 minutes

    • Record vital signs (HR, B/P, resp rate, O2 sat)
    • Obtain and assess pain response scores

      1. Pain Numerical Rating Score (NRS - 0-10)
      2. Richmond Agitation Sedation Scale (RASS)
      3. Side Effect Rating Scale for Dissociative Anesthesia (SERSDA)
    • Record any airway interventions required? If yes what? new supplemental O2/BVM/intubation, jaw thrust
    • Record any rescue meds, dose and time (Rescue medication - Fentanyl):
    • 1 mcg/kg IV fentanyl (0.5 mcg/kg if age >55 yrs)
    • Defined as rescue if given <30 min post study intervention for pain score >5 or patient requesting additional medication.
    • Patient pain satisfaction score at discharge
    Intervention: Drug: Fentanyl
  • Experimental: Ketamine

    Drug administration: A single dose of ketamine 0.3 mg/kg IV over 15 minutes. Time drug given will be documented Data obtained prior to med administration and then following medication administration at intervals of 15, 30, 60 and 120 minutes

    • Record vital signs (HR, B/P, resp rate, O2 sat)
    • Obtain and assess pain response scores

      1. Pain Numerical Rating Score (NRS - 0-10)
      2. Richmond Agitation Sedation Scale (RASS)
      3. Side Effect Rating Scale for Dissociative Anesthesia (SERSDA)
    • Record any airway interventions required? If yes what? new supplemental O2/BVM/intubation, jaw thrust
    • Record any rescue meds, dose and time (Rescue medication - Fentanyl):
    • 1 mcg/kg IV fentanyl (0.5 mcg/kg if age >55 yrs)
    • Defined as rescue if given <30 min post study intervention for pain score >5 or patient requesting additional medication.
    • Patient pain satisfaction score at discharge
    Intervention: Drug: Ketamine
Publications *

*   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 Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 10, 2022)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages ≥ 18 years.
  • Able to speak and understand English.
  • RSE requiring IV pain medication for NRS pain score > 5.
  • No allergy to ketamine or fentanyl.
  • Ability to provide informed consent.
  • ≤ 24 hours from envenomation.

Exclusion Criteria:

  • Pregnant or lactating.
  • Prisoners.
  • Refugees.
  • History of schizophrenia.
  • Clinically intoxicated.
  • On buprenorphine therapy.
  • History of uncontrolled hypertension
  • Increased intracranial pressure
  • Systemic envenomation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05379179
Other Study ID Numbers  ICMJE STUDY00000919
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.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.
Current Responsible Party Meghan Spyres, University of Arizona
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Meghan Spyres
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Meghan Spyres, MD University of Arizona
PRS Account University of Arizona
Verification Date September 2022

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