A Phase 4 interventional study of Ketamine in Pain, Acute and Dissociation, sponsored by Summa Health System. Completed at 1 site in United States. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Summa Health System · Phase 4, Interventional, and Treatment
This will be an intent to treat prospective, double blind, double-dummy, randomized trial. Our primary objective is the reduction of side effects of sub dissociative dose ketamine given by slow intravenous (IV) infusion over 30 minutes vs. 15 minutes in the treatment of acute, severe pain in Emergency Department (ED) patients. The secondary objective will be to maintain adequate pain control (as defined by a Visual Analog Scale (VAS) score of ≤ 5cm) at 30 minutes for both groups.
Previous research has shown that low dose ketamine (LDK) Intravenous push (IVP) (0.3mg/kg) to have equivalent pain reduction in moderate to severe acute pain in the Emergency Department (ED) when compared to standard of care of morphine intravenous push (IVP) (0.1mg/kg). Ketamine has been shown to produce side effects in these studies, including dizziness, feeling of unreality and mood changes, but no unexpected side effects or adverse events. Additional studies have compared IVP with slower infusion of low dose ketamine (LDK) and have shown a decrease in side effects while maintaining similar analgesic efficacy. This previous trial found increased feelings of unreality for the IVP group (difference of 37.5%) as well as increased rates of sedation.
In clinical practice, increasing the time/duration of the infusion has resulted in a decrease of reported side effects from patients while still maintaining analgesia. There have been no studies done to prove that there is a further reduction in side effects with a longer LDK infusion. The investigators believe that increasing the infusion time to greater than 15 minutes will reduce the frequency and intensity of expected side effects of ketamine felt by participants and allow for further use of ketamine as a non-opiate analgesic in the ED.
Overall aims of project:
Hypothesis: Slow infusion of low dose ketamine (LDK) over 30 minutes will provide adequate pain control (as defined by VAS score of ≤5 cm), and reduce incidence and severity (by at least 20% or 1 point on SERSDA scale) of known side effects when compared to LDK given over 15 minutes in moderate to severe acute pain for patients presenting to the ED.
Study Design
The location of this study will be the Akron City Hospital Emergency Department. The trial will enroll approximately 48 participants over a 24-month enrollment period.
This will be an intent to treat prospective, double blind, double-dummy, randomized trial. The primary outcome will be a comparison of side effects of sub dissociative dose ketamine given by slow IV infusion over 15 minutes vs 30 minutes in treatment of moderate to severe acute pain in ED patients. The secondary outcome will be adequate pain control (VAS ≤5 cm), and need for rescue analgesia between the two groups.
The control group will receive slow IV infusion of ketamine over 15 minutes. The experimental group will receive slow IV infusion of ketamine over 30 minutes.
If the potential participant meets all eligibility criteria, they will be consented by study staff members and then randomized to receive Ketamine 0.25mg/kg in 100cc normal saline (NS) as IV infusion over specified time as well as "placebo" 100cc NS over the other time slot.
Pharmacy staff will blind medication as well as provide medication in a blinded fashion to the nurse who will use infusion pumps to deliver both study medication and placebo simultaneously. Nursing staff will receive training on administration of medication prior to starting the study.
The investigators will measure the side effect profile using the Side Effects Rating Scale for Dissociative Anesthetics (SERSDA) along with the VAS (visual analog scale) scores from 0-100mm.
Vital signs (heart rate, blood pressure, respiratory rate and oxygen saturation) will also be obtained at 0, 5, 15, 30, 60, and 90 minutes from the start of the ketamine/NS placebo infusion.
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's enrollment of 55 is below the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Summa Health System is the lead sponsor of 20 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 15 minutes.
Drug: Ketamine
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 30 minutes.
Drug: Ketamine
Administration of Ketamine
Also known as: Ketalar
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Composite Score
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).
Time frame: 30 minutes
Visual Analog Scale (VAS) Score
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.
Time frame: 30 minutes
Richmond Agitation-Sedation Scale
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.
Time frame: 30 Minutes
Recruited subjects from December 2022 to April 2025 at the Emergency Department at Akron City Hospital.
| Milestone | Ketamine 15 Minutes | Ketamine 30 Minutes |
|---|---|---|
| Started | 29 | 26 |
| Completed | 24 | 24 |
| Not completed | 5 | 2 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Screen fail at baseline assessment | 2 | 2 |
| Withdrew: Required more urgent form of pain control | 1 | 0 |
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).
| Scores on a Scale | Ketamine 15 Minutes | Ketamine 30 Minutes |
|---|---|---|
| 5 Minutes Post Infusion | 1.88 ± 0.57 | 0.42 ± 0.25 |
| 30 Minutes Post Infusion | 1.17 ± 0.39 | 3.67 ± 0.86 |
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.
| Millimeters (mm) | Ketamine 15 Minutes | Ketamine 30 Minutes |
|---|---|---|
| Baseline | 82.21 ± 14.78 | 88.38 ± 13.8 |
| 30 Minute Infusion | 41.25 ± 30.41 | 56.08 ± 34.87 |
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.
| Points on Scale | Ketamine 15 Minutes | Ketamine 30 Minutes |
|---|---|---|
| 5 Minutes Post Infusion | -0.08 ± 0.28 | -0.04 ± 0.20 |
| 30 Minutes Post Infusion | -0.21 ± 0.51 | -0.29 ± 0.46 |
Collected over 90 Minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ketamine 15 Minutes | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Ketamine 30 Minutes | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Age, Categorical(Participants) | Ketamine 15 Minutes | Ketamine 30 Minutes | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 21 | 42 |
| >=65 years | 3 | 3 | 6 |
| Sex: Female, Male(Participants) | Ketamine 15 Minutes | Ketamine 30 Minutes | Total |
|---|---|---|---|
| Female | 12 | 12 | 24 |
| Male | 12 | 12 | 24 |
| Race and Ethnicity Not Collected(Participants) | Ketamine 15 Minutes | Ketamine 30 Minutes | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Ketamine 15 Minutes | Ketamine 30 Minutes | Total |
|---|---|---|---|
| United States | 24 | 24 | 48 |
| Visual Analog Scale(millimeters) | Ketamine 15 Minutes | Ketamine 30 Minutes | Total |
|---|---|---|---|
| Mean | 82.21 ± 14.78 | 88.38 ± 13.80 | 85.3 ± 14.50 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Ketamine
Summa Health System