RECRUITING

Ketamine as a Supplement to Local Anesthesia for Minor Procedures

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 trial is a double-blind randomized controlled clinical trial of adults and children (ages 7 to less than 70 years). Patients who present to the ED and who undergo minor bedside procedures that require local anesthesia will be divided into two groups: The first group will be treated with 0.7 mg/kg intranasal ketamine as well as standard local anesthesia for the procedure (treatment cohort). The second group will be treated with a volume-based dose of intranasal saline solution as well as standard local anesthesia for the procedure (control cohort). The primary aim is to assess whether patients in the treatment cohort report lower pain scores on the Numerical Rating Scale (NRS-100) when compared to patients in the control cohort. For adult patients, a secondary aim is to compare agitation between the two cohorts using the Richmond Agitation Sedation Scale (RASS) and, for pediatric patients, a secondary aim is to compare alertness between the two cohorts using the University of Michigan Sedation Scale (UMSS). Results obtained from specific procedures will be analyzed on a spectrum of complexity and general length of recovery time. Scientific achievements may include finding a safe and effective way to reduce pain and discomfort during minor procedures in the Emergency Department. Additionally, it would provide opportunities for more research on sub-dissociative doses of ketamine during minor procedures: a topic in which there is still a gap in the published research

Official Title

Intranasal Ketamine as a Supplement to Local Anesthesia to Reduce Pain Associated With Minor Procedures in the Emergency Department

Quick Facts

Study Start:2022-05-25
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06284473

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:7 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Undergoing Minor Procedure in the ED
  2. * Weight not to exceed 115kg
  1. * Altered Mental Status
  2. * Pregnancy
  3. * Breastfeeding
  4. * Acute head or eye injury
  5. * Intercranial Hypertension
  6. * Hx of seizures
  7. * Hx of chronic pain
  8. * Unstable vital signs
  9. * Allergy to Ketamine
  10. * Hepatic or Renal Insufficiency
  11. * Hx of Psychiatric Illness
  12. * Hx of alcohol/drug abuse

Contacts and Locations

Study Contact

Shannon Lovett, MD
CONTACT
708-327-2549
slovett@lumc.edu
Trent Reed, DO
CONTACT
708-216-4117
treed1@lumc.edu

Principal Investigator

Trent Reed, DO
PRINCIPAL_INVESTIGATOR
Loyola University

Study Locations (Sites)

Loyola University Medical Center
Maywood, Illinois, 60153
United States

Collaborators and Investigators

Sponsor: Loyola University

  • Trent Reed, DO, PRINCIPAL_INVESTIGATOR, Loyola University

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 Date2022-05-25
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2022-05-25
Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

  • IN Ketamine
  • Sub-dissociative dose
  • Minor procedure

Additional Relevant MeSH Terms

  • Pain, Procedural
  • Minor Laceration
  • Abscess