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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

55 participants

Primary outcome timeframe

30 minutes

Results posted on

2026-04-13

Participant Flow

Recruited subjects from December 2022 to April 2025 at the Emergency Department at Akron City Hospital.

Participant milestones

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

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

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 minutes

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).

Outcome measures

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 minutes

The 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

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 Minutes

The 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ketamine 30 Minutes

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

Dr. Michael Pallaci, DO, FACEP

Summa Health

Phone: (800) 421-0925

Results disclosure agreements

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