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Opioid Analgesic
Ketamine vs Fentanyl for Rattlesnake Bite Pain
Phase 4
Waitlist Available
Led By Meghan Spyres, MD
Research Sponsored by Meghan Spyres
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages ≥ 18 years.
RSE requiring IV pain medication for NRS pain score > 5.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30-120 minutes after drug administration
Awards & highlights
Study Summary
This trial will compare the effectiveness of two approved medications, ketamine and fentanyl, for the treatment of pain after rattlesnake envenomation.
Who is the study for?
This trial is for adults over 18 who've been bitten by a rattlesnake, need IV pain medication, and can consent to the study. They must not be allergic to ketamine or fentanyl, pregnant, have schizophrenia, uncontrolled high blood pressure, increased brain pressure or be intoxicated.Check my eligibility
What is being tested?
The study tests how effective a single dose of ketamine compares with fentanyl in managing pain after a rattlesnake bite. Patients will report their pain levels following treatment at Banner - University Medical Center Phoenix.See study design
What are the potential side effects?
Ketamine may cause changes in blood pressure, dizziness, nausea, disorientation or hallucinations. Fentanyl can lead to drowsiness, nausea, constipation or respiratory depression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I need IV pain medication for severe pain.
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I was bitten or stung by a venomous creature less than 24 hours ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30-120 minutes after drug administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30-120 minutes after drug administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Pain Assessment Post Medication
Secondary outcome measures
Adverse Events
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: KetamineExperimental Treatment1 Intervention
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
Group II: FentanylActive Control1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
Meghan SpyresLead Sponsor
Meghan Spyres, MDPrincipal InvestigatorUniversity of Arizona
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need IV pain medication for severe pain.I was bitten or stung by a venomous creature less than 24 hours ago.I have high pressure inside my skull.I am currently taking buprenorphine.I have high blood pressure that isn't well-controlled.You have been diagnosed with schizophrenia in the past.I am 18 years old or older.I have been poisoned by a bite or sting.Individuals who have fled their home country due to conflict or persecution.
Research Study Groups:
This trial has the following groups:- Group 1: Fentanyl
- Group 2: Ketamine
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants currently enrolling in this experiment?
"According to clinicaltrials.gov, this specific trial has ceased searching for new participants since the last update on September 11th 2022. However, there are 19 other medical experiments that are actively recruiting individuals as of now."
Answered by AI
Does the Food and Drug Administration consider Ketamine a safe therapy?
"The safety rating of Ketamine is a 3, as it has already gone through its fourth phase clinical trial and been approved by relevant governing bodies."
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Is the enrollment for this experiment confined to adults age 18 or older?
"As outlined in the admission requirements, this clinical trial is open to participants between 18 and 100 years of age."
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Which individuals are eligible to participate in the experimental procedure?
"Qualified participants for this trial must have experienced a rattlesnake bite and be within the ages of 18 to 100 years old. Approximately 40 patients are being gathered by the research team."
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