COMPLETED

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

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Conditions

Pain, AcuteDissociation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2022-12-07
Study Completion:2025-04-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05518877

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.

Ages Eligible for Study:18 Years to 110 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients aged 18 or older
  2. * Primary complaint of acute moderate to severe pain on VAS/ numeric pain scale (a score of ≥5cm which corresponds to 50mm).
  3. * Pain described as abdominal, flank, back, musculoskeletal, or traumatic chest pain
  4. * Must be alert and oriented times three
  5. * Able to provide consent
  1. * Pregnant
  2. * Breastfeeding
  3. * Altered mental status
  4. * Known or reported allergy, hypersensitivity or intolerance to ketamine
  5. * 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)
  6. * History of unstable heart disease, such as arrhythmias, congestive heart failure, or coronary heart disease.
  7. * History of untreated or uncontrolled thyroid disease
  8. * Acute head or eye injury
  9. * Active or current use of alcohol or drugs
  10. * Known intracranial hypertension
  11. * Hepatic or renal insufficiency
  12. * Current active manic phase of bipolar disorder
  13. * Active delusions, hallucinations, or schizophrenia
  14. * Patients who have recent fentanyl use within 60 minutes or other analgesic use (opiates) within 4 hours of study enrollment (signing of consent)
  15. * Patients who have enrolled in the study during a previous ED encounter
  16. * Chronic use of opiates (i.e.: fentanyl patch, SR opiates)

Contacts and Locations

Principal Investigator

Michael Pallaci, DO, FACEP
PRINCIPAL_INVESTIGATOR
Summa Health System

Study Locations (Sites)

Summa Health System
Akron, Ohio, 44304
United States

Collaborators and Investigators

Sponsor: Summa Health System

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-07
Study Completion Date2025-04-02

Study Record Updates

Study Start Date2022-12-07
Study Completion Date2025-04-02

Terms related to this study

Additional Relevant MeSH Terms

  • Pain, Acute
  • Dissociation