RecruitingPhase 4ketamine

Ketamine as a Supplement to Local Anesthesia for Minor Procedures

Sponsored by Loyola University

NCT ID
NCT06284473
Target Enrollment
108 participants
Start Date
2022-05-25
Est. Completion
2028-05-31

About This Study

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 Studied

Pain, ProceduralMinor LacerationAbscess

Interventions

  • Ketamine
  • Saline

Eligibility

Age:7 Years - 70 Years
Healthy Volunteers:No
View full eligibility criteria
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 Locations (1)

Loyola University Medical Center
Maywood, Illinois, United States

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Shannon Lovett, MD
CONTACT
708-327-2549slovett@lumc.edu
Trent Reed, DO
CONTACT
708-216-4117treed1@lumc.edu
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source