Trial Outcomes & Findings for Comparison of Nebulized Ketamine to Intravenous Sub-Dissociative Dose Ketamine for Pain (NCT NCT04947085)

Results Overview

The primary outcome of this trial is the comparative change in participant's pain scores at 30 minutes post medication administration. Pain score is measured in a 11 point Likert Scale where 0 is no pain and 10 is extreme pain; 5 is moderate pain.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

150 participants

Primary outcome timeframe

30 minutes

Results posted on

2024-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	IV SDK intravenous ketamine administration in sub-dissociative doses (SDK) administered at 0.3 mg/kg over 15 minutes to patients presenting to the ED of Maimonides Medical Center with acute and chronic painful conditions. Ketamine via Intravenous: Ketamine administration in sub-dissociative doses	K-BAN nebulized ketamine at 0.75mg/kg administered via BAN to patients presenting to the ED of Maimonides Medical Center with acute and chronic painful conditions. Ketamine via BAN: Ketamine administered via Breath-Actuated Nebulizer (BAN)
Overall Study STARTED	75	75
Overall Study COMPLETED	72	75
Overall Study NOT COMPLETED	3	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	IV SDK n=75 Participants intravenous ketamine administration in sub-dissociative doses (SDK) administered at 0.3 mg/kg over 15 minutes to patients presenting to the ED of Maimonides Medical Center with acute and chronic painful conditions. Ketamine via Intravenous: Ketamine administration in sub-dissociative doses	K-BAN n=75 Participants nebulized ketamine at 0.75mg/kg administered via BAN to patients presenting to the ED of Maimonides Medical Center with acute and chronic painful conditions. Ketamine via BAN: Ketamine administered via Breath-Actuated Nebulizer (BAN)	Total n=150 Participants Total of all reporting groups
Age, Continuous	46 years STANDARD_DEVIATION 13 • n=75 Participants	47 years STANDARD_DEVIATION 16 • n=75 Participants	46.6 years STANDARD_DEVIATION 14.4 • n=150 Participants
Sex: Female, Male Female	41 Participants n=75 Participants	39 Participants n=75 Participants	80 Participants n=150 Participants
Sex: Female, Male Male	34 Participants n=75 Participants	36 Participants n=75 Participants	70 Participants n=150 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	75 participants n=75 Participants	75 participants n=75 Participants	150 participants n=150 Participants

PRIMARY outcome

Timeframe: 30 minutes

The primary outcome of this trial is the comparative change in participant's pain scores at 30 minutes post medication administration. Pain score is measured in a 11 point Likert Scale where 0 is no pain and 10 is extreme pain; 5 is moderate pain.

Outcome measures

Outcome measures
Measure	IV SDK n=72 Participants intravenous ketamine administration in sub-dissociative doses (SDK) administered at 0.3 mg/kg over 15 minutes to patients presenting to the ED of Maimonides Medical Center with acute and chronic painful conditions. Ketamine via Intravenous: Ketamine administration in sub-dissociative doses	K-BAN n=75 Participants nebulized ketamine at 0.75mg/kg administered via BAN to patients presenting to the ED of Maimonides Medical Center with acute and chronic painful conditions. Ketamine via BAN: Ketamine administered via Breath-Actuated Nebulizer (BAN)
Change in in Pain Score at 30 Minutes	4.7 score on a scale Standard Deviation 3.2	4.5 score on a scale Standard Deviation 2.8

Adverse Events

IV SDK

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

K-BAN

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

Sergey Motov

Maimonides Medical Center

Phone: 718-283-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place