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

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
COMPLETED
2
1
Overall Study
NOT COMPLETED
0
0
Overall Study
STARTED
2
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ketamine Pilot Study

Baseline characteristics by cohort

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=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Female
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Male
2 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=99 Participants
0 Participants
n=107 Participants
2 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
White
2 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Region of Enrollment
United States
2 participants
n=99 Participants
1 participants
n=107 Participants
3 participants
n=206 Participants

PRIMARY outcome

Timeframe: 30-120 minutes after drug administration

Population: 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

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
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
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

SECONDARY outcome

Timeframe: During hospitalization, up to 120 minutes

A subjects chart will be reviewed to determine whether rescue medication was needed or if there were any adverse medications effects

Outcome measures

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

Jessica Winters

University of Arizona

Phone: 520-780-1882

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place