Trial Outcomes & Findings for Nebulized Sub-dissociative Dose Ketamine for Treating Pain (NCT NCT03909607)

NCT ID: NCT03909607

Last Updated: 2022-06-15

Results Overview

Patients will be assessed via an 11 point Likert numeric rating scale at time medication is given (baseline) and 30 minutes later. The difference in pain scores will be assessed between the 3 groups. The numeric rating scale range is from 0 to 10 with 0 being no pain and 10 being very severe pain.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 120 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2022-06-15

Participant Flow

Participant milestones

Measure	SDK 0.75 mg/kg The patients will receive sub-dissociative ketamine at a dose of 0.75mg/k Ketamine 0.75 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 0.75mg/kg	SDK 1.0 mg/kg The patients will receive sub-dissociative ketamine at a dose of 1.0mg/k Ketamine 1.0 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.0 mg/kg	SDK 1.5 mg/kg The patients will receive sub-dissociative ketamine at a dose of 1.5mg/k Ketamine 1.5 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.5 mg/kg
Overall Study STARTED	40	40	40
Overall Study COMPLETED	35	36	38
Overall Study NOT COMPLETED	5	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	SDK 0.75 mg/kg n=40 Participants The patients will receive sub-dissociative ketamine at a dose of 0.75mg/k Ketamine 0.75 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 0.75mg/kg	SDK 1.0 mg/kg n=40 Participants The patients will receive sub-dissociative ketamine at a dose of 1.0mg/k Ketamine 1.0 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.0 mg/kg	SDK 1.5 mg/kg n=40 Participants The patients will receive sub-dissociative ketamine at a dose of 1.5mg/k Ketamine 1.5 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.5 mg/kg	Total n=120 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 20 • n=40 Participants	51 years STANDARD_DEVIATION 16 • n=40 Participants	50 years STANDARD_DEVIATION 18 • n=40 Participants	51 years STANDARD_DEVIATION 18 • n=120 Participants
Sex: Female, Male Female	23 Participants n=40 Participants	22 Participants n=40 Participants	23 Participants n=40 Participants	68 Participants n=120 Participants
Sex: Female, Male Male	17 Participants n=40 Participants	18 Participants n=40 Participants	17 Participants n=40 Participants	52 Participants n=120 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	40 participants n=40 Participants	40 participants n=40 Participants	40 participants n=40 Participants	120 participants n=120 Participants

PRIMARY outcome

Timeframe: 30 minutes

Patients will be assessed via an 11 point Likert numeric rating scale at time medication is given (baseline) and 30 minutes later. The difference in pain scores will be assessed between the 3 groups. The numeric rating scale range is from 0 to 10 with 0 being no pain and 10 being very severe pain.

Outcome measures

Measure	SDK 0.75 mg/kg n=40 Participants The patients will receive sub-dissociative ketamine at a dose of 0.75mg/k Ketamine 0.75 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 0.75mg/kg	SDK 1.0 mg/kg n=40 Participants The patients will receive sub-dissociative ketamine at a dose of 1.0mg/k Ketamine 1.0 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.0 mg/kg	SDK 1.5 mg/kg n=40 Participants The patients will receive sub-dissociative ketamine at a dose of 1.5mg/k Ketamine 1.5 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.5 mg/kg
Change in Pain Scores From Baseline to 30 Minutes	4.0 units on a scale Standard Deviation 1.9	4.2 units on a scale Standard Deviation 2.1	4.1 units on a scale Standard Deviation 1.9

Adverse Events

SDK 0.75 mg/kg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

SDK 1.0 mg/kg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

SDK 1.5 mg/kg

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SDK 0.75 mg/kg n=40 participants at risk The patients will receive sub-dissociative ketamine at a dose of 0.75mg/k Ketamine 0.75 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 0.75mg/kg	SDK 1.0 mg/kg n=40 participants at risk The patients will receive sub-dissociative ketamine at a dose of 1.0mg/k Ketamine 1.0 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.0 mg/kg	SDK 1.5 mg/kg n=40 participants at risk The patients will receive sub-dissociative ketamine at a dose of 1.5mg/k Ketamine 1.5 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.5 mg/kg
Nervous system disorders Dizzines	12.5% 5/40 • Number of events 5 • 120 minutes	35.0% 14/40 • Number of events 14 • 120 minutes	37.5% 15/40 • Number of events 15 • 120 minutes

Additional Information

Sergey Motov MD

Maimonides Medical Center

Phone: 718-283-8693

Email: smotov@maimonidesmed.org

Results disclosure agreements

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