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

Description

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

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Study Overview

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Study Details

Study overview

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.

Low Dose Ketamine Infusion for Analgesia in the Emergency Department (ED) to Reduce Side Effects: A Double Blind, Double Dummy Randomized Controlled Trial

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

Condition
Pain, Acute
Intervention / Treatment

-

Contacts and Locations

Akron

Summa Health System, Akron, Ohio, United States, 44304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * Chronic use of opiates (i.e.: fentanyl patch, SR opiates)

Ages Eligible for Study

18 Years to 110 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Summa Health System,

Michael Pallaci, DO, FACEP, PRINCIPAL_INVESTIGATOR, Summa Health System

Study Record Dates

2025-11-30