Recruiting

Ketamine

Sponsor:

Loyola University

Code:

NCT06284473

Conditions

Pain, Procedural

Minor Laceration

Abscess

Eligibility Criteria

Sex: All

Age: 7 - 70

Healthy Volunteers: Not accepted

Interventions

Ketamine

Saline

Study Details

Brief 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

Conditions

Pain, Procedural

Minor Laceration

Abscess

Study ID

NCT06284473

Start date

May 25, 2022

Status verified date

Sep, 2025

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Ketamine

Ketamine is an N-methyl-D aspartate receptor agonist

Saline

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

Primary outcome measure

  • Immediate pain [ Time Frame: 15 minutes ]
  • Acute pain [ Time Frame: 30 minutes ]
  • Delayed pain [ Time Frame: 60 minutes ]

Central Contacts and Locations

Central contacts

Locations

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

More Information

Sponsor

Loyola University

Last update posted

Oct 3, 2025

Last verified

Sep, 2025

Keywords

  • IN Ketamine
  • Sub-dissociative dose
  • Minor procedure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2025-10-03.