Ketamine as a Supplement to Local Anesthesia for Minor Procedures

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age7-70
SponsorLoyola University

About this trial

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 criteria

Qualifiers

Undergoing Minor Procedure in the ED

Weight not to exceed 115kg

Disqualifiers

Altered Mental Status

Pregnancy

Breastfeeding

Acute head or eye injury

Trial design

Treatments tested in this trial

  • Ketamine
  • Saline

Treatment groups

108 Participants
are divided into 2 treatment groups

Sponsors and collaborators