protocolSection identificationModule nctId: NCT06284473, orgStudyIdInfo id: 212154, briefTitle: Ketamine as a Supplement to Local Anesthesia for Minor Procedures, acronym: INK-MP, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-25, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Loyola University, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: Pain, Procedural, conditions: Minor Laceration, conditions: Abscess, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients presenting to the emergency department at Loyola University Medical Center for a minor medical procedure requiring local anesthesia will be randomly assigned to receive either standard local anesthesia with 0.7 mg/kg intranasal ketamine before the procedure or to standard local anesthesia with volume-based dose saline before the procedure using a 1:1 random block allocation., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All participants and study personnel are blinded except for the clinical pharmacist who prepares the intervention., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Ketamine, interventions name: Saline, outcomesModule primaryOutcomes measure: Immediate pain, primaryOutcomes measure: Acute pain, primaryOutcomes measure: Delayed pain, secondaryOutcomes measure: Immediate agitation, secondaryOutcomes measure: Acute agitation, secondaryOutcomes measure: Delayed agitation, secondaryOutcomes measure: Immediate alertness, secondaryOutcomes measure: Acute alertness, secondaryOutcomes measure: Delayed alertness, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Loyola University Medical Center, status: RECRUITING, city: Maywood, state: Illinois, zip: 60153, country: United States, contacts name: Shannon Lovett, MD, role: CONTACT, phone: 847-951-2936, email: slovett@lumc.edu, contacts name: Trent Reed, DO, role: CONTACT, phone: 708-216-4117, email: treed1@lumc.edu, geoPoint lat: 41.8792, lon: -87.84312, hasResults: False