TerminatedPhase 4ketamine

Ketamine Pilot Study

Sponsored by Meghan Spyres

NCT ID
NCT05379179
Target Enrollment
3 participants
Start Date
2022-06-20
Est. Completion
2022-08-27

About This Study

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 Studied

Rattlesnake Envenomation

Interventions

  • Ketamine
  • Fentanyl

Eligibility

Age:18 Years - 100 Years
Healthy Volunteers:No
View full 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

Study Locations (1)

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

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source