Phase 4 N=55 Randomized Quadruple-blind Treatment

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

Pain, Acute · Dissociation

Bottom Line

View on ClinicalTrials.gov: NCT05518877 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Composite Score — 1.88; 0.42; 1.17; 3.67 Scores on a Scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ketamine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Summa Health System
Primary completion: Apr 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Composite Score	1.88; 0.42; 1.17; 3.67	<0.001 sig
SECONDARY Visual Analog Scale (VAS) Score	82.21; 88.38; 41.25; 56.08	0.1232
SECONDARY Richmond Agitation-Sedation Scale	-0.08; -0.04; -0.21; -0.29	0.5563

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.

Eligibility Criteria

Inclusion criteria

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

Exclusion criteria

Pregnant
Breastfeeding
Altered mental status
Known or reported allergy, hypersensitivity or intolerance to ketamine
Unstable vital signs (systolic blood pressure 180mmHg, heart rate 150 beats per minute, and respiratory rate 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
Chronic use of opiates (i.e.: fentanyl patch, SR opiates)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05518877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.