Trial Outcomes & Findings for Low Dose Ketamine Infusion for Analgesia in the Emergency Department to Reduce Side Effects (NCT NCT05518877)
NCT ID: NCT05518877
Last Updated: 2026-04-13
Results Overview
The Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) is a clinician administered tool used to evaluate acute side effects associated with ketamine infusion. The composite scale is a measure of the effects including fatigue, dizziness, headache, feeling of unreality, hearing, vision, or mood changes, generalized discomfort, and hallucinations. The SERSDA composite score is the mean overall score of nine adverse events on a scale of 0 (no adverse effect) to 36 (very bothersome effect).
COMPLETED
PHASE4
55 participants
30 minutes
2026-04-13
Participant Flow
Recruited subjects from December 2022 to April 2025 at the Emergency Department at Akron City Hospital.
Participant milestones
| Measure |
Ketamine 15 Minutes
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 15 minutes.
Ketamine: Administration of Ketamine
|
Ketamine 30 Minutes
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 30 minutes.
Ketamine: Administration of Ketamine
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
26
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Ketamine 15 Minutes
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 15 minutes.
Ketamine: Administration of Ketamine
|
Ketamine 30 Minutes
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 30 minutes.
Ketamine: Administration of Ketamine
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Screen Fail at Baseline Assessment
|
2
|
2
|
|
Overall Study
Required More Urgent Form of Pain Control
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ketamine 15 Minutes
n=24 Participants
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 15 minutes.
Ketamine: Administration of Ketamine
|
Ketamine 30 Minutes
n=24 Participants
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 30 minutes.
Ketamine: Administration of Ketamine
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=24 Participants
|
21 Participants
n=24 Participants
|
42 Participants
n=48 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=24 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=48 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
24 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
24 Participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
24 participants
n=24 Participants
|
48 participants
n=48 Participants
|
|
Visual Analog Scale
|
82.21 millimeters
STANDARD_DEVIATION 14.78 • n=24 Participants
|
88.38 millimeters
STANDARD_DEVIATION 13.80 • n=24 Participants
|
85.3 millimeters
STANDARD_DEVIATION 14.50 • n=48 Participants
|
PRIMARY outcome
Timeframe: 30 minutesThe Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) is a clinician administered tool used to evaluate acute side effects associated with ketamine infusion. The composite scale is a measure of the effects including fatigue, dizziness, headache, feeling of unreality, hearing, vision, or mood changes, generalized discomfort, and hallucinations. The SERSDA composite score is the mean overall score of nine adverse events on a scale of 0 (no adverse effect) to 36 (very bothersome effect).
Outcome measures
| Measure |
Ketamine 15 Minutes
n=24 Participants
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 15 minutes.
Ketamine: Administration of Ketamine
|
Ketamine 30 Minutes
n=24 Participants
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 30 minutes.
Ketamine: Administration of Ketamine
|
|---|---|---|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Composite Score
5 Minutes Post Infusion
|
1.88 Scores on a Scale
Standard Deviation 0.57
|
0.42 Scores on a Scale
Standard Deviation 0.25
|
|
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Composite Score
30 Minutes Post Infusion
|
1.17 Scores on a Scale
Standard Deviation 0.39
|
3.67 Scores on a Scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: 30 minutesThe visual analog scale is a validated, patient reported subjective measure for acute and chronic pain intensity. The sale consists of a 10cm (100mm) horizontal line anchored by "no pain" (0) and "worst imaginable pain" (10). Participants indicate their level by marking a point on the line. The score is quantified in millimeters from the "no pain" anchor, with higher values indicating greater pain severity.
Outcome measures
| Measure |
Ketamine 15 Minutes
n=24 Participants
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 15 minutes.
Ketamine: Administration of Ketamine
|
Ketamine 30 Minutes
n=24 Participants
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 30 minutes.
Ketamine: Administration of Ketamine
|
|---|---|---|
|
Visual Analog Scale (VAS) Score
Baseline
|
82.21 Millimeters (mm)
Standard Deviation 14.78
|
88.38 Millimeters (mm)
Standard Deviation 13.8
|
|
Visual Analog Scale (VAS) Score
30 Minute Infusion
|
41.25 Millimeters (mm)
Standard Deviation 30.41
|
56.08 Millimeters (mm)
Standard Deviation 34.87
|
SECONDARY outcome
Timeframe: 30 MinutesThe Richmond Agitation-Sedation Scale (RASS) is a validated, clinician administered tool used to assess a patient's level of arousal, agitation, or sedation. The scale ranges from +4 (combative) to 0 (alert and calm) to -5 (unarousable) allowing standardized characterization of agitation and sedation states. Higher positive scores indicate increasing agitation, while more negative scores indicate deeper levels of sedation.
Outcome measures
| Measure |
Ketamine 15 Minutes
n=24 Participants
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 15 minutes.
Ketamine: Administration of Ketamine
|
Ketamine 30 Minutes
n=24 Participants
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 30 minutes.
Ketamine: Administration of Ketamine
|
|---|---|---|
|
Richmond Agitation-Sedation Scale
5 Minutes Post Infusion
|
-0.08 Points on Scale
Standard Deviation 0.28
|
-0.04 Points on Scale
Standard Deviation 0.20
|
|
Richmond Agitation-Sedation Scale
30 Minutes Post Infusion
|
-0.21 Points on Scale
Standard Deviation 0.51
|
-0.29 Points on Scale
Standard Deviation 0.46
|
Adverse Events
Ketamine 15 Minutes
Ketamine 30 Minutes
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