Ketamine Pilot Study

NCT05379179 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: STUDY00000919
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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).

Conditions

Rattlesnake Envenomation

Keywords

Acute pain after rattlesnake bite; Rattlesnake envenomation; low dose ketamine; pain dose ketamine

Outcome Measures

Primary Outcomes (1)

• 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.

  30-120 minutes after drug administration

Secondary Outcomes (1)

• Adverse Events

  During hospitalization, up to 120 minutes

Study Arms (2)

Fentanyl

ACTIVE COMPARATOR

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

Ketamine

EXPERIMENTAL

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

Interventions

Ketamine DRUG

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.

Ketamine

Fentanyl DRUG

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.

Fentanyl

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or lactating.
• Prisoners.
• Refugees.
• History of schizophrenia.
• Clinically intoxicated.
• On buprenorphine therapy.
• History of uncontrolled hypertension
• Increased intracranial pressure
• Systemic envenomation

Sponsors & Collaborators

• Meghan Spyres: lead

Study Sites (1)

Banner - University Medical Center, Phoenix campus

Phoenix, Arizona, 85006, United States

Location

Related Publications (5)

• 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.

  PMID: 30019434 BACKGROUND

• 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.

  PMID: 32891662 BACKGROUND

• 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.

  PMID: 33098707 BACKGROUND

• 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.

  PMID: 24127709 BACKGROUND

• 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.

  PMID: 11719741 BACKGROUND

MeSH Terms

Interventions

Ketamine; Fentanyl

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Significant limitations were not reaching the target number of patients, extremely low enrollment resulted in termination.

Results Point of Contact

• Title: Jessica Winters
• Organization: University of Arizona

jwinters1@arizona.edu

520-780-1882

Study Officials

• Meghan Spyres, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Emergency Medicine

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: May 18, 2022
• Study Start: June 20, 2022
• Primary Completion: August 27, 2022
• Study Completion: August 27, 2022
• Last Updated: February 14, 2024
• Results First Posted: February 14, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)