Ketamine Pilot Study

January 23, 2024 updated by: Meghan Spyres

Pilot Study: Ketamine for Acute Pain After Rattlesnake Envenomation

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner - University Medical Center, Phoenix campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30-120 minutes after drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During hospitalization, up to 120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meghan Spyres

Investigators

  • Principal Investigator: Meghan Spyres, MD, University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2022

Primary Completion (Actual)

August 27, 2022

Study Completion (Actual)

August 27, 2022

Study Registration Dates

First Submitted

April 15, 2022

First Submitted That Met QC Criteria

May 10, 2022

First Posted (Actual)

May 18, 2022

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000919

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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