Ketamine Pilot Study

Sponsor

Meghan Spyres (Other)

Overall Status

Recruiting

CT.gov ID

NCT05379179

Collaborator

(none)

Enrollment

Location

Arms

10.3

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Rattlesnake Envenomation	Drug: Ketamine Drug: Fentanyl	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

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.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

Official Title:

Pilot Study: Ketamine for Acute Pain After Rattlesnake Envenomation

Actual Study Start Date :

Jun 20, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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 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: 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 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: 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.

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 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: 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 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: 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.

Outcome Measures

Primary Outcome Measures

Change in Pain assessment post medication [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.

Secondary Outcome Measures

Adverse Events [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner - University Medical Center, Phoenix campus	Phoenix	Arizona	United States	85006

Sponsors and Collaborators

Meghan Spyres

Investigators

Principal Investigator: Meghan Spyres, MD, University of Arizona

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Meghan Spyres, Associate Professor, Emergency Medicine, University of Arizona

ClinicalTrials.gov Identifier:

NCT05379179

Other Study ID Numbers:

STUDY00000919

First Posted:

May 18, 2022

Last Update Posted:

Aug 2, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Meghan Spyres, Associate Professor, Emergency Medicine, University of Arizona

Acute pain after rattlesnake bite

Rattlesnake envenomation

low dose ketamine

pain dose ketamine

Additional relevant MeSH terms:

Poisoning

Fentanyl

Ketamine

Study Results

No Results Posted as of Aug 2, 2022