Low Dose Ketamine Infusion for Analgesia in the Emergency Department to Reduce Side Effects

NCT05518877 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 22194
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pain, Acute; Dissociation

Outcome Measures

Primary Outcomes (1)

• 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).

  30 minutes

Secondary Outcomes (2)

• Visual Analog Scale (VAS) Score

  30 minutes

• Richmond Agitation-Sedation Scale

  30 Minutes

Study Arms (2)

Ketamine 15 Minutes

ACTIVE COMPARATOR

Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 15 minutes.

Drug: Ketamine

Ketamine 30 Minutes

EXPERIMENTAL

Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 30 minutes.

Drug: Ketamine

Interventions

Ketamine DRUG

Administration of Ketamine

Also known as: Ketalar

Ketamine 15 Minutes; Ketamine 30 Minutes

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Summa Health System: lead

Study Sites (1)

Summa Health System

Akron, Ohio, 44304, United States

Location

Related Publications (2)

• 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.

  PMID: 25817884 BACKGROUND

• Motov 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.

  PMID: 28283340 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Dissociative Disorders

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Due to lack of software availability, the statistical analysis was conducted using SAS instead of SPSS.

Results Point of Contact

• Title: Dr. Michael Pallaci, DO, FACEP
• Organization: Summa Health

research@summahealth.org

(800) 421-0925

Study Officials

• Michael Pallaci, DO, FACEP

  Summa Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, double-dummy randomized controlled trial

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: August 29, 2022
• Study Start: December 7, 2022
• Primary Completion: April 2, 2025
• Study Completion: April 2, 2025
• Last Updated: April 13, 2026
• Results First Posted: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)