Ketamine as a Supplement to Local Anesthesia for Minor Procedures

Part of paid clinical trials in Maywood, Illinois.

Sponsor
Loyola University
Study ID
NCT06284473
Phase
PHASE4
Status
Recruiting
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Conditions

  • Abscess
  • Minor Laceration
  • Pain, Procedural

Eligibility Criteria

Sex
ALL
Age
7 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketamine — DRUG
    Ketamine is an N-methyl-D aspartate receptor agonist
  • Saline — OTHER
    Intranasal saline flushes pollen, dust, and other debris from nasal passages. It also removes excess mucus and adds moisture

Study Details

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 Dates

Start date
May 25, 2022
Status verified
Sep 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intranasal Ketamine
    Participants assigned to this arm will receive intranasal ketamine administered at 0.7mg/kg along with normal lidocaine local sedation
  • Placebo Comparator: Placebo
    Participants assigned to this arm will receive volume-based dose of intranasal saline administered along with normal lidocaine local sedation

Primary Outcome Measure

Immediate pain [ Time Frame: 15 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Loyola University Medical CenterMaywoodIllinois60153
Shannon Lovett, MD
[email protected]
8479512936
Trent Reed, DO
[email protected]
708-216-4117

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By research site
Loyola University Medical Center· Maywood, IL

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