Ketamine as a Supplement to Local Anesthesia for Minor Procedures

NCT06284473 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 212154
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

IN Ketamine; Sub-dissociative dose; Minor procedure

Outcome Measures

Primary Outcomes (3)

• Immediate pain

  Pain will be measured using the numeric rating scale which is a scale ranging from 0 to 100, where higher values report greater pain

  15 minutes

• Acute pain

  Pain will be measured using the numeric rating scale which is a scale ranging from 0 to 100, where higher values report greater pain

  30 minutes

• Delayed pain

  Pain will be measured using the numeric rating scale which is a scale ranging from 0 to 100, where higher values report greater pain

  60 minutes

Secondary Outcomes (6)

• Immediate agitation

  15 minutes

• Acute agitation

  30 minutes

• Delayed agitation

  60 minutes

• Immediate alertness

  15 minutes

• Acute alertness

  30 minutes

Study Arms (2)

Intranasal Ketamine

EXPERIMENTAL

Participants assigned to this arm will receive intranasal ketamine administered at 0.7mg/kg along with normal lidocaine local sedation

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

Participants assigned to this arm will receive volume-based dose of intranasal saline administered along with normal lidocaine local sedation

Other: Saline

Interventions

Ketamine DRUG

Ketamine is an N-methyl-D aspartate receptor agonist

Intranasal Ketamine

Saline OTHER

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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 7 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Related Publications (15)

• Shimonovich S, Gigi R, Shapira A, Sarig-Meth T, Nadav D, Rozenek M, West D, Halpern P. Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety. BMC Emerg Med. 2016 Nov 9;16(1):43. doi: 10.1186/s12873-016-0107-0.

  PMID: 27829367 BACKGROUND

• Beaudoin FL, Lin C, Guan W, Merchant RC. Low-dose ketamine improves pain relief in patients receiving intravenous opioids for acute pain in the emergency department: results of a randomized, double-blind, clinical trial. Acad Emerg Med. 2014 Nov;21(11):1193-202. doi: 10.1111/acem.12510.

  PMID: 25377395 BACKGROUND

• Motov S, Rockoff B, Cohen V, Pushkar I, Likourezos A, McKay C, Soleyman-Zomalan E, Homel P, Terentiev V, Fromm C. Intravenous Subdissociative-Dose Ketamine Versus Morphine for Analgesia in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2015 Sep;66(3):222-229.e1. doi: 10.1016/j.annemergmed.2015.03.004. Epub 2015 Mar 26.

  PMID: 25817884 BACKGROUND

• Zekry O, Gibson SB, Aggarwal A. Subanesthetic, Subcutaneous Ketamine Infusion Therapy in the Treatment of Chronic Nonmalignant Pain. J Pain Palliat Care Pharmacother. 2016 Jun;30(2):91-8. doi: 10.3109/15360288.2016.1161690. Epub 2016 Apr 19.

  PMID: 27092576 BACKGROUND

• Hanna AF, Armstrong JS, Smith AJ. Effects of Intravenous Ketamine Infusions in a Neuropathic Pain Patient with Lichen Sclerosus et Atrophicus. Case Rep Dermatol. 2016 Jun 6;8(2):164-70. doi: 10.1159/000446528. eCollection 2016 May-Aug.

  PMID: 27462225 BACKGROUND

• Miller JP, Schauer SG, Ganem VJ, Bebarta VS. Low-dose ketamine vs morphine for acute pain in the ED: a randomized controlled trial. Am J Emerg Med. 2015 Mar;33(3):402-8. doi: 10.1016/j.ajem.2014.12.058. Epub 2015 Jan 7.

  PMID: 25624076 BACKGROUND

• Karlow N, Schlaepfer CH, Stoll CRT, Doering M, Carpenter CR, Colditz GA, Motov S, Miller J, Schwarz ES. A Systematic Review and Meta-analysis of Ketamine as an Alternative to Opioids for Acute Pain in the Emergency Department. Acad Emerg Med. 2018 Oct;25(10):1086-1097. doi: 10.1111/acem.13502. Epub 2018 Jul 17.

  PMID: 30019434 BACKGROUND

• Optimizing the Treatment of Acute Pain in the Emergency Department. Ann Emerg Med. 2017 Sep;70(3):446-448. doi: 10.1016/j.annemergmed.2017.06.043. No abstract available.

  PMID: 28844277 BACKGROUND

• Payne CG, Edbrooke DL, Davies GK. Minor procedures in the accident and emergency department: can Entonox help? Arch Emerg Med. 1991 Mar;8(1):24-32. doi: 10.1136/emj.8.1.24.

  PMID: 1854389 BACKGROUND

• Allen CA, Ivester JR Jr. Ketamine for Pain Management-Side Effects & Potential Adverse Events. Pain Manag Nurs. 2017 Dec;18(6):372-377. doi: 10.1016/j.pmn.2017.05.006. Epub 2017 Jul 23.

  PMID: 28743507 BACKGROUND

• Lee EN, Lee JH. The Effects of Low-Dose Ketamine on Acute Pain in an Emergency Setting: A Systematic Review and Meta-Analysis. PLoS One. 2016 Oct 27;11(10):e0165461. doi: 10.1371/journal.pone.0165461. eCollection 2016.

  PMID: 27788221 BACKGROUND

• Reynolds SL, Studnek JR, Bryant K, VanderHave K, Grossman E, Moore CG, Young J, Hogg M, Runyon MS. Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department. BMJ Open. 2016 Sep 8;6(9):e012190. doi: 10.1136/bmjopen-2016-012190.

  PMID: 27609854 BACKGROUND

• Shrestha R, Pant S, Shrestha A, Batajoo KH, Thapa R, Vaidya S. Intranasal ketamine for the treatment of patients with acute pain in the emergency department. World J Emerg Med. 2016;7(1):19-24. doi: 10.5847/wjem.j.1920-8642.2016.01.003.

  PMID: 27006733 BACKGROUND

• Reynolds SL, Bryant KK, Studnek JR, Hogg M, Dunn C, Templin MA, Moore CG, Young JR, Walker KR, Runyon MS. Randomized Controlled Feasibility Trial of Intranasal Ketamine Compared to Intranasal Fentanyl for Analgesia in Children with Suspected Extremity Fractures. Acad Emerg Med. 2017 Dec;24(12):1430-1440. doi: 10.1111/acem.13313. Epub 2017 Nov 3.

  PMID: 28926159 BACKGROUND

• Bouida W, Bel Haj Ali K, Ben Soltane H, Msolli MA, Boubaker H, Sekma A, Beltaief K, Grissa MH, Methamem M, Boukef R, Belguith A, Nouira S. Effect on Opioids Requirement of Early Administration of Intranasal Ketamine for Acute Traumatic Pain. Clin J Pain. 2020 Jun;36(6):458-462. doi: 10.1097/AJP.0000000000000821.

  PMID: 32080000 BACKGROUND

MeSH Terms

Conditions

Pain, Procedural; Abscess

Interventions

Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Suppuration; Infections; Inflammation; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Trent Reed, DO

  Loyola University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon Lovett, MD

CONTACT

708-327-2549; slovett@lumc.edu

Trent Reed, DO

CONTACT

708-216-4117; treed1@lumc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants and study personnel are blinded except for the clinical pharmacist who prepares the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: May 25, 2022
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)