Trial Outcomes & Findings for Ketamine for Pain in the Emergency Department (NCT NCT03896230)

Last Updated: 2023-06-07

Results Overview

Pain score using Numerical Rating Scale (NRS) post ketamine infusion. The Numerical Rating Scale (NRS) ranges from 0-to-10 with 0 being no pain and lower numbers representing less pain, so in this case lower numbers will represent better outcomes. Pain scores were reported at baseline and then at 15 min/30 min/60 min/90 min and 120 minutes post-infusion.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

Within 2 hours post infusion completion

Results posted on

2023-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: 0.1 mg/kg Ketamine 0.1 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion. Ketamine Injectable Product: Three different doses of ketamine will be administered.	Arm 1: 0.2 mg/kg Ketamine 0.2 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion. Ketamine Injectable Product: Three different doses of ketamine will be administered.	Arm 1: 0.3 mg/kg Ketamine 0.3 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion. Ketamine Injectable Product: Three different doses of ketamine will be administered.
Overall Study STARTED	5	4	2
Overall Study COMPLETED	5	4	2
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: 0.2 mg/kg Ketamine n=4 Participants 0.2 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion. Ketamine Injectable Product: Three different doses of ketamine will be administered.	Arm 1: 0.1 mg/kg Ketamine n=5 Participants 0.1 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion. Ketamine Injectable Product: Three different doses of ketamine will be administered.	Arm 1: 0.3 mg/kg Ketamine n=2 Participants 0.3 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion. Ketamine Injectable Product: Three different doses of ketamine will be administered.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=2 Participants	0 Participants n=11 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants	4 Participants n=5 Participants	1 Participants n=2 Participants	9 Participants n=11 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	1 Participants n=5 Participants	1 Participants n=2 Participants	2 Participants n=11 Participants
Age, Continuous	50.5 years n=4 Participants	47.4 years n=5 Participants	68 years n=2 Participants	52.3 years n=11 Participants
Sex: Female, Male Female	3 Participants n=4 Participants	2 Participants n=5 Participants	2 Participants n=2 Participants	7 Participants n=11 Participants
Sex: Female, Male Male	1 Participants n=4 Participants	3 Participants n=5 Participants	0 Participants n=2 Participants	4 Participants n=11 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	4 Participants n=4 Participants	5 Participants n=5 Participants	2 Participants n=2 Participants	11 Participants n=11 Participants

PRIMARY outcome

Timeframe: Within 2 hours post infusion completion

Population: A different number of patients was available for the pain score measurement at the different timepoints. Two patients did not complete infusion, one in the "0.1 mg/kg ketamine" group and one in the "0.3 mg/kg ketamine" group.

Outcome measures

Outcome measures
Measure	Arm 1: 0.1 mg/kg Ketamine n=5 Participants 0.1 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion. Ketamine Injectable Product: Three different doses of ketamine will be administered.	Arm 1: 0.2 mg/kg Ketamine n=4 Participants 0.2 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion. Ketamine Injectable Product: Three different doses of ketamine will be administered.	Arm 1: 0.3 mg/kg Ketamine n=2 Participants 0.3 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion. Ketamine Injectable Product: Three different doses of ketamine will be administered.
Pain Score Baseline pain score	9.4 score on a scale Interval 9.0 to 10.0	8.5 score on a scale Interval 7.0 to 10.0	7.5 score on a scale Interval 5.0 to 10.0
Pain Score Pain score at 15 min	5.25 score on a scale Interval 2.0 to 9.0	6 score on a scale Interval 5.0 to 7.0	2 score on a scale Interval 2.0 to 2.0
Pain Score Pain score at 30 min	5.25 score on a scale Interval 2.0 to 10.0	5.75 score on a scale Interval 0.0 to 9.0	6 score on a scale Interval 6.0 to 6.0
Pain Score Pain score at 60 min	5.25 score on a scale Interval 2.0 to 10.0	7 score on a scale Interval 5.0 to 9.0	5 score on a scale Interval 5.0 to 5.0
Pain Score Pain score at 90 min	4.5 score on a scale Interval 2.0 to 7.0	7 score on a scale Interval 7.0 to 7.0	2 score on a scale Interval 2.0 to 2.0
Pain Score Pain score at 120 min	4 score on a scale Interval 3.0 to 5.0	—	—

SECONDARY outcome

Timeframe: Within 2 hours post infusion completion

Population: Number of patients reporting adverse events in the two hours post infusion. Two patients did not complete infusion, one in the "0.1 mg/kg ketamine" group and one in the "0.3 mg/kg ketamine" group and they are not included in the AE reporting.

Frequency of adverse events secondary to ketamine including fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing or vision, mood changes, generalized discomfort, and hallucinations, changes in vital signs. Adverse events were reported at baseline and then at 15 min/30 min/60 min/90 min and 120 minutes post-infusion.

Outcome measures

Outcome measures
Measure	Arm 1: 0.1 mg/kg Ketamine n=5 Participants 0.1 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion. Ketamine Injectable Product: Three different doses of ketamine will be administered.	Arm 1: 0.2 mg/kg Ketamine n=4 Participants 0.2 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion. Ketamine Injectable Product: Three different doses of ketamine will be administered.	Arm 1: 0.3 mg/kg Ketamine n=2 Participants 0.3 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion. Ketamine Injectable Product: Three different doses of ketamine will be administered.
Adverse Events at 15 min post infusion	2 participants	3 participants	2 participants
Adverse Events at 30 min post infusion	1 participants	2 participants	1 participants
Adverse Events at 60 min post infusion	1 participants	2 participants	0 participants
Adverse Events at 90 min post infusion	1 participants	2 participants	0 participants
Adverse Events at 120 min post infusion	1 participants	0 participants	0 participants

Adverse Events

Arm 1: 0.1 mg/kg Ketamine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm 1: 0.2 mg/kg Ketamine

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm 1: 0.3 mg/kg Ketamine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm 1: 0.1 mg/kg Ketamine n=5 participants at risk 0.1 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion. Ketamine Injectable Product: Three different doses of ketamine will be administered.	Arm 1: 0.2 mg/kg Ketamine n=4 participants at risk 0.2 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion. Ketamine Injectable Product: Three different doses of ketamine will be administered.	Arm 1: 0.3 mg/kg Ketamine n=2 participants at risk 0.3 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion. Ketamine Injectable Product: Three different doses of ketamine will be administered.
General disorders Dizziness	40.0% 2/5 • Number of events 3 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	75.0% 3/4 • Number of events 5 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	50.0% 1/2 • Number of events 2 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".
Eye disorders Changes in vision	20.0% 1/5 • Number of events 5 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	25.0% 1/4 • Number of events 1 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	50.0% 1/2 • Number of events 1 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".
General disorders Generalized discomfort	40.0% 2/5 • Number of events 5 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	50.0% 2/4 • Number of events 7 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	100.0% 2/2 • Number of events 3 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".
Nervous system disorders Headache	20.0% 1/5 • Number of events 1 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	25.0% 1/4 • Number of events 1 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	0.00% 0/2 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".
General disorders Unreality	20.0% 1/5 • Number of events 1 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	75.0% 3/4 • Number of events 7 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	100.0% 2/2 • Number of events 3 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".
General disorders Fatigue	20.0% 1/5 • Number of events 3 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	50.0% 2/4 • Number of events 6 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	0.00% 0/2 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 2 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	0.00% 0/4 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	0.00% 0/2 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".
Psychiatric disorders Mood change	0.00% 0/5 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	25.0% 1/4 • Number of events 1 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	0.00% 0/2 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".
Psychiatric disorders Hallucination	0.00% 0/5 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	25.0% 1/4 • Number of events 1 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".	50.0% 1/2 • Number of events 2 • Adverse events were collected for 2 hours post infusion. All adverse events were reported in a systematic manner. A 0-4 scale was used with 0 being "no adverse event" and 4 being "very bothersome adverse event".

Additional Information

Gabrielle L. Procopio, Pharm.D., BCPS

Hackensack Meridian Health

Phone: 551-996-4368

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place