Actively Recruiting

Phase 4
Age: 7Years - 70Years
All Genders
NCT06284473

Ketamine as a Supplement to Local Anesthesia for Minor Procedures

Led by Loyola University · Updated on 2025-10-03

108

Participants Needed

1

Research Sites

314 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Ketamine as a Supplement to Local Anesthesia for Minor Procedures

Who Can Participate

Age: 7Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing minor procedure in the emergency department
  • Weight not to exceed 115 kg
  • Age between 7 and less than 70 years
Not Eligible

You will not qualify if you...

  • Altered mental status
  • Pregnancy
  • Breastfeeding
  • Acute head or eye injury
  • Intracranial hypertension
  • History of seizures
  • History of chronic pain
  • Unstable vital signs
  • Allergy to ketamine
  • Liver or kidney insufficiency
  • History of psychiatric illness
  • History of alcohol or drug abuse

AI-Screening

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Trial Site Locations

Total: 1 location

1

Loyola University Medical Center

Maywood, Illinois, United States, 60153

Actively Recruiting

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Research Team

S

Shannon Lovett, MD

CONTACT

T

Trent Reed, DO

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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