Rattlesnake EnvenomationPhase 4NCT05379179
Ketamine Pilot Study
A Phase 4 study testing Ketamine and Fentanyl in people with Rattlesnake Envenomation, run by Meghan Spyres at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rattlesnake Envenomation
- What is being tested?
- Ketamine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2022to 27 Aug 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant or lactating.
- Prisoners.
- Refugees.
- History of schizophrenia.
- Clinically intoxicated.
- On buprenorphine therapy.
Show all 9Show fewer
- History of uncontrolled hypertension
- Increased intracranial pressure
- Systemic envenomation
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner - University Medical Center, Phoenix campus
Phoenix, Arizona, 85006
About this study
Official title: 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).
Read the 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.
- Conditions
- Rattlesnake Envenomation
- Keywords
- Acute pain after rattlesnake bite, Rattlesnake envenomation, low dose ketamine, pain dose ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
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.
FentanylDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30-120 minutes after drug administration
Secondary outcomes (1)
Adverse Events
A subjects chart will be reviewed to determine whether rescue medication was needed or if there were any adverse medications effects
Measured: During hospitalization, up to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start20 Jun 2022
- Primary completion27 Aug 2022
- Study completion27 Aug 2022
Why it stopped: After 20 months of active enrollment and a lack of qualified/interested subjects, the Investigator, Meghan Spyres, MD, decided to terminate recruitment before meeting the stated enrollment objectives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rattlesnake EnvenomationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meghan Spyres
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Meghan Spyres, University of Arizona
- Investigators
- Meghan Spyres, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379179
- Sponsor's protocol ID
- STUDY00000919
- Status last verified
- Jan 2024
- First submitted
- 15 Apr 2022
- Last updated
- 14 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
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.
PubMed 30019434Brandehoff 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.
PubMed 32891662Balzer 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.
PubMed 33098707Andolfatto 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.
PubMed 24127709Gallagher 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.
PubMed 11719741
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Ketamine for Acute Pain After Rattlesnake Envenomation
- ClinicalTrials.gov ID
- NCT05379179
- Acronym / sponsor ID
- STUDY00000919
- Conditions
- Rattlesnake Envenomation
- Keywords
- Acute pain after rattlesnake bite, Rattlesnake envenomation, low dose ketamine, pain dose ketamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After 20 months of active enrollment and a lack of qualified/interested subjects, the Investigator, Meghan Spyres, MD, decided to terminate recruitment before meeting the stated enrollment objectives.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Meghan SpyresUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 27 Aug 2022 (actual)
- Study completion
- 27 Aug 2022 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Posted 14 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Active comparator | Drug: FentanylDrug 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 |
| Ketamine | Experimental | Drug: KetamineDrug 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- Pregnant or lactating.
- Prisoners.
- Refugees.
- History of schizophrenia.
- Clinically intoxicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineThis study will compare patient-reported pain scores after receiving either ketamine or fentanyl for the treatment of acute pain due to a rattlesnake bite. | Drug | Ketamine |
| FentanylThis study will compare patient-reported pain scores after receiving either ketamine or fentanyl for the treatment of acute pain due to a rattlesnake bite. | Drug | Fentanyl |
Primary outcome
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.
1 secondary outcome
Adverse Events
Time frame: During hospitalization, up to 120 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30019434Karlow 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.
- Background: PubMed 32891662Brandehoff 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.
- Background: PubMed 33098707Balzer 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.
- Background: PubMed 24127709Andolfatto 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.
- Background: PubMed 11719741Gallagher 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan Spyres, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Fentanyl in people with Rattlesnake Envenomation, run by Meghan Spyres at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Assessment Post Medication (time frame: 30-120 minutes after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05379179, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.