Ketamine as a Supplement to Local Anesthesia for Minor Procedures

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Pain, Procedural, Minor Laceration, Abscess

In brief

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

Key facts

Study ID

NCT06284473

Run by

Loyola University

People needed

108

Starts

2022-05-25

Expected to finish

2028-05-31

Last updated by the study team

2025-10-03

Who can join

Age: 7 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Undergoing Minor Procedure in the ED
• Weight not to exceed 115kg

You may not qualify if…

• Altered Mental Status
• Pregnancy
• Breastfeeding
• Acute head or eye injury
• Intercranial Hypertension
• Hx of seizures
• Hx of chronic pain
• Unstable vital signs
• Allergy to Ketamine
• Hepatic or Renal Insufficiency
• Hx of Psychiatric Illness
• Hx of alcohol/drug abuse

Where it is running

• Loyola University Medical Center — Maywood, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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