Pain, AcutePhase 4NCT05518877
Low Dose Ketamine Infusion for Analgesia in the Emergency Department to Reduce Side Effects
A Phase 4 study testing Ketamine in people with Pain, Acute and Dissociation, run by Summa Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Pain, Acute, Dissociation
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2022to 2 Apr 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 or older
- Primary complaint of acute moderate to severe pain on VAS/ numeric pain scale (a score of ≥5cm which corresponds to 50mm).
- Pain described as abdominal, flank, back, musculoskeletal, or traumatic chest pain
- Must be alert and oriented times three
- Able to provide consent
Who cannot join
- Pregnant
- Breastfeeding
- Altered mental status
- Known or reported allergy, hypersensitivity or intolerance to ketamine
- Unstable vital signs (systolic blood pressure <80 or >180mmHg, heart rate <50 or >150 beats per minute, and respiratory rate <10 or >30 breaths per minute)
- History of unstable heart disease, such as arrhythmias, congestive heart failure, or coronary heart disease.
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- History of untreated or uncontrolled thyroid disease
- Acute head or eye injury
- Active or current use of alcohol or drugs
- Known intracranial hypertension
- Hepatic or renal insufficiency
- Current active manic phase of bipolar disorder
- Active delusions, hallucinations, or schizophrenia
- Patients who have recent fentanyl use within 60 minutes or other analgesic use (opiates) within 4 hours of study enrollment (signing of consent)
- Patients who have enrolled in the study during a previous ED encounter
- Chronic use of opiates (i.e.: fentanyl patch, SR opiates)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Dose Ketamine Infusion for Analgesia in the Emergency Department (ED) to Reduce Side Effects: A Double Blind, Double Dummy Randomized Controlled Trial
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.
Read the detailed description
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:
- Reduce overall side effects of low dose ketamine when given over 30 minutes versus 15 minutes.
- Maintain adequate pain control, as defined by a Visual Analogue Scale (VAS) score of ≤5 cm at 30 minutes for both groups.
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.
- Conditions
- Pain, Acute, Dissociation
- Being tested
- Ketamine
- Medical subject headings
- Acute Pain, Dissociative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Administration of Ketamine
| Study group | Role | What they receive |
|---|---|---|
| Ketamine 15 Minutes | Active comparator | Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 15 minutes. Receives: Drug: Ketamine |
| Ketamine 30 Minutes | Experimental | Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 30 minutes. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 minutes
Secondary outcomes (2)
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.
Measured: 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.
Measured: 30 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start7 Dec 2022
- Primary completion2 Apr 2025
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, double-dummy randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Summa Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Pallaci, DO, FACEP, Principal investigator, Summa Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518877
- Sponsor's protocol ID
- 22194
- Status last verified
- Mar 2026
- First submitted
- 15 Apr 2022
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Motov S, Rockoff B, Cohen V, Pushkar I, Likourezos A, McKay C, Soleyman-Zomalan E, Homel P, Terentiev V, Fromm C. Intravenous Subdissociative-Dose Ketamine Versus Morphine for Analgesia in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2015 Sep;66(3):222-229.e1. doi: 10.1016/j.annemergmed.2015.03.004. Epub 2015 Mar 26.
PubMed 25817884Motov S, Mai M, Pushkar I, Likourezos A, Drapkin J, Yasavolian M, Brady J, Homel P, Fromm C. A prospective randomized, double-dummy trial comparing IV push low dose ketamine to short infusion of low dose ketamine for treatment of pain in the ED. Am J Emerg Med. 2017 Aug;35(8):1095-1100. doi: 10.1016/j.ajem.2017.03.004. Epub 2017 Mar 3.
PubMed 28283340
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Ketamine Infusion for Analgesia in the Emergency Department (ED) to Reduce Side Effects: A Double Blind, Double Dummy Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05518877
- Acronym / sponsor ID
- 22194
- Conditions
- Pain, Acute, Dissociation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Summa Health SystemUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Posted 13 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Reduce overall side effects of low dose ketamine when given over 30 minutes versus 15 minutes.
- Maintain adequate pain control, as defined by a Visual Analogue Scale (VAS) score of ≤5 cm at 30 minutes for both groups.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, double-dummy randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Ketamine 15 Minutes | Active comparator | Drug: KetamineParticipants receive 0.25mg/kg Ketamine dose intravenous for pain over 15 minutes. |
| Ketamine 30 Minutes | Experimental | Drug: KetamineParticipants receive 0.25mg/kg Ketamine dose intravenous for pain over 30 minutes. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 or older
- Primary complaint of acute moderate to severe pain on VAS/ numeric pain scale (a score of ≥5cm which corresponds to 50mm).
- Pain described as abdominal, flank, back, musculoskeletal, or traumatic chest pain
- Must be alert and oriented times three
- Able to provide consent
Key exclusion criteria (16 listed)
- Pregnant
- Breastfeeding
- Altered mental status
- Known or reported allergy, hypersensitivity or intolerance to ketamine
- Unstable vital signs (systolic blood pressure <80 or >180mmHg, heart rate <50 or >150 beats per minute, and respiratory rate <10 or >30 breaths per minute)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: KetalarAdministration of Ketamine | Drug | Ketamine 15 Minutes, Ketamine 30 Minutes |
Primary outcome
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Composite Score
Time frame: 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).
2 secondary outcomes
Visual Analog Scale (VAS) Score
Time frame: 30 minutes
Richmond Agitation-Sedation Scale
Time frame: 30 Minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25817884Motov S, Rockoff B, Cohen V, Pushkar I, Likourezos A, McKay C, Soleyman-Zomalan E, Homel P, Terentiev V, Fromm C. Intravenous Subdissociative-Dose Ketamine Versus Morphine for Analgesia in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2015 Sep;66(3):222-229.e1. doi: 10.1016/j.annemergmed.2015.03.004. Epub 2015 Mar 26.
- Background: PubMed 28283340Motov S, Mai M, Pushkar I, Likourezos A, Drapkin J, Yasavolian M, Brady J, Homel P, Fromm C. A prospective randomized, double-dummy trial comparing IV push low dose ketamine to short infusion of low dose ketamine for treatment of pain in the ED. Am J Emerg Med. 2017 Aug;35(8):1095-1100. doi: 10.1016/j.ajem.2017.03.004. Epub 2017 Mar 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Pallaci, DO, FACEP principal investigator
Summa Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine in people with Pain, Acute and Dissociation, run by Summa Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Composite Score (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05518877, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.