search
Back to results

Ketamine Pilot Study

Primary Purpose

Rattlesnake Envenomation

Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Fentanyl
Sponsored by
Meghan Spyres
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rattlesnake Envenomation focused on measuring Acute pain after rattlesnake bite, Rattlesnake envenomation, low dose ketamine, pain dose ketamine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner - University Medical Center, Phoenix campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fentanyl

Ketamine

Arm Description

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 Pain Numerical Rating Score (NRS - 0-10) Richmond Agitation Sedation Scale (RASS) 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

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 Pain Numerical Rating Score (NRS - 0-10) Richmond Agitation Sedation Scale (RASS) 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

Outcomes

Primary Outcome Measures

Change in Pain assessment post medication
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.

Secondary Outcome Measures

Adverse Events
A subjects chart will be reviewed to determine whether rescue medication was needed or if there were any adverse medications effects

Full Information

First Posted
April 15, 2022
Last Updated
April 21, 2023
Sponsor
Meghan Spyres
search

1. Study Identification

Unique Protocol Identification Number
NCT05379179
Brief Title
Ketamine Pilot Study
Official Title
Pilot Study: Ketamine for Acute Pain After Rattlesnake Envenomation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Meghan Spyres

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.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rattlesnake Envenomation
Keywords
Acute pain after rattlesnake bite, Rattlesnake envenomation, low dose ketamine, pain dose ketamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
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 Pain Numerical Rating Score (NRS - 0-10) Richmond Agitation Sedation Scale (RASS) 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
Arm Title
Ketamine
Arm Type
Experimental
Arm Description
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 Pain Numerical Rating Score (NRS - 0-10) Richmond Agitation Sedation Scale (RASS) 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 Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain assessment post medication
Description
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.
Time Frame
30-120 minutes after drug administration
Secondary Outcome Measure Information:
Title
Adverse Events
Description
A subjects chart will be reviewed to determine whether rescue medication was needed or if there were any adverse medications effects
Time Frame
During hospitalization, up to 120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meghan Spyres, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner - University Medical Center, Phoenix campus
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
Citations:
PubMed Identifier
30019434
Citation
Karlow N, Schlaepfer CH, Stoll CRT, Doering M, Carpenter CR, Colditz GA, Motov S, Miller J, Schwarz ES. A Systematic Review and Meta-analysis of Ketamine as an Alternative to Opioids for Acute Pain in the Emergency Department. Acad Emerg Med. 2018 Oct;25(10):1086-1097. doi: 10.1111/acem.13502. Epub 2018 Jul 17.
Results Reference
background
PubMed Identifier
32891662
Citation
Brandehoff N, Benjamin JM, Balde C, Chippaux JP. Ketamine for pain control of snake envenomation in Guinea: A case series. Toxicon. 2020 Nov;187:82-85. doi: 10.1016/j.toxicon.2020.08.020. Epub 2020 Sep 3.
Results Reference
background
PubMed Identifier
33098707
Citation
Balzer N, McLeod SL, Walsh C, Grewal K. Low-dose Ketamine For Acute Pain Control in the Emergency Department: A Systematic Review and Meta-analysis. Acad Emerg Med. 2021 Apr;28(4):444-454. doi: 10.1111/acem.14159. Epub 2021 Jan 2.
Results Reference
background
PubMed Identifier
24127709
Citation
Andolfatto G, Willman E, Joo D, Miller P, Wong WB, Koehn M, Dobson R, Angus E, Moadebi S. Intranasal ketamine for analgesia in the emergency department: a prospective observational series. Acad Emerg Med. 2013 Oct;20(10):1050-4. doi: 10.1111/acem.12229.
Results Reference
background
PubMed Identifier
11719741
Citation
Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.
Results Reference
background

Learn more about this trial

Ketamine Pilot Study

We'll reach out to this number within 24 hrs