Trial Outcomes & Findings for Ketamine Pilot Study (NCT NCT05379179)
NCT ID: NCT05379179
Last Updated: 2024-02-14
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
3 participants
Primary outcome timeframe
30-120 minutes after drug administration
Results posted on
2024-02-14
Participant Flow
Participants were recruited from patients hospitalized with rattlesnake bites at Banner University Medical Center between 05/2022 and 01/2024. The first participant was enrolled on 06/20/2022, and the last was enrolled in 08/2022.
Of the 3 enrolled participants, 3 met inclusion criteria and were randomized.
Participant milestones
| Measure |
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
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
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.
|
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
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: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine Pilot Study
Baseline characteristics by cohort
| Measure |
Fentanyl
n=2 Participants
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
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.
|
Ketamine
n=1 Participants
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
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.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30-120 minutes after drug administrationPopulation: Note there was only 1 patient in the Ketamine group thus medians represent this single patient value, no range calculated.
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.
Outcome measures
| Measure |
Fentanyl
n=2 Participants
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
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.
|
Ketamine
n=1 Participants
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
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.
|
|---|---|---|
|
Change in Pain Assessment Post Medication
60 minutes
|
1.5 units on a scale
Interval 1.25 to 1.75
|
5 units on a scale
|
|
Change in Pain Assessment Post Medication
120 minutes
|
1.5 units on a scale
Interval 1.25 to 1.75
|
10 units on a scale
|
|
Change in Pain Assessment Post Medication
30 minutes
|
1 units on a scale
Interval 1.0 to 1.0
|
10 units on a scale
|
SECONDARY outcome
Timeframe: During hospitalization, up to 120 minutesA subjects chart will be reviewed to determine whether rescue medication was needed or if there were any adverse medications effects
Outcome measures
| Measure |
Fentanyl
n=2 Participants
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
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.
|
Ketamine
n=1 Participants
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
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.
|
|---|---|---|
|
Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
Fentanyl
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place