RecruitingPhase 4NCT06284473

Ketamine as a Supplement to Local Anesthesia for Minor Procedures

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


Sponsor

Loyola University

Enrollment

108 participants

Start Date

May 25, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 7 YearsMax Age: 70 Years

Inclusion Criteria2

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

Exclusion Criteria12

  • 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

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Interventions

DRUGKetamine

Ketamine is an N-methyl-D aspartate receptor agonist

OTHERSaline

Intranasal saline flushes pollen, dust, and other debris from nasal passages. It also removes excess mucus and adds moisture


Locations(1)

Loyola University Medical Center

Maywood, Illinois, United States

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NCT06284473


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