A Phase 4 interventional study of Ketamine and Saline in Pain, Procedural, Minor Laceration and Abscess, sponsored by Loyola University. Recruiting at 1 site in United States. Open to participants aged 7 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Loyola University · Phase 4, Interventional, and Treatment
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
Patient experiences in the emergency department (ED) are commonly painful and uncomfortable, particularly when patients must undergo procedures. Managing acute pain and procedural pain for minor procedures in the ED can be challenging. Ketamine is an N-methyl-D aspartate receptor agonist gaining popularity in clinical settings and has also been shown in several studies to potentially treat depression. Several randomized clinical studies have shown that ketamine is a comparable pain relief medication to opioid analgesics in both acute pain and traumatic settings. Its uses for pain control in the ED have been extensively studied with evidence supporting its safety and efficacy. Ketamine can be administered in different ways including intravenously and intranasally. Intravenously, doses above 1 mg/kg of ketamine can induce dissociation- this dose is commonly used for procedural sedation. At lower doses, specifically sub-dissociative doses, ketamine (SDK) acts to alleviate pain (cancerous, neuropathic, and perioperative). Trials using intravenous SDK suggest efficacy similar to traditional intravenous opioid analgesics.
SDK is currently being utilized by emergency medicine physicians in the ED for pain control in doses up to 0.3 mg/kg intravenously and up to 1 mg/kg intranasally. Additionally, the use of SDK in the ED is also supported by the American College of Emergency Physicians. While the literature has extensively documented and supported the safety and efficacy of SDK, there is a gap in the literature for its use in the management of pain for minor procedures in the ED. Intranasal ketamine may be a valuable supplement to standard medical treatment in procedures that would not normally require intravenous access. Minor procedures requiring local anesthesia performed in the ED can still be painful including but not limited to suturing, incision and drainage of an abscess, and digital blocks. Traditionally, many of these procedures are completed using only local anesthesia. Soft tissue and/or very large abscess are sometimes not alleviated by local anesthesia alone. The use of intranasal ketamine to alleviate pain during these and other painful procedures may provide patients with more comfort and pain relief than local anesthesia alone. Dosing for chronic pain and acute pain differ in that chronic pain typically requires higher doses than acute pain. Side effects are related to ketamine dosage and administration type. Thus, patients treated for chronic pain with higher doses of SDK often experience more side effects than patients with acute pain treated with lower doses of SDK. Additionally, compared to placebo and opioid groups in various studies, ketamine was associated with greater risk of neurological, psychological, and minor cardiologic effects. However, the opioid groups typically had a higher risk for major cardiopulmonary effects. The most common side effect of intranasal SDK are bad taste in the mouth, dizziness, and sleepiness. A dose of 0.7 mg/kg IN ketamine has been determined to be a suitable analgesic dose for patients with pain in the ED. While studies have shown the efficacy and safety of using ketamine for pain control, no studies to date have looked at its possible use to decrease pain during minor procedures in the ED.
The investigators aim to determine if a sub-dissociative dose of 0.7 mg/kg intranasal ketamine is a desirable choice to reduce pain associated with minor procedures requiring local anesthesia in the ED. These procedures include incision and drainage of an abscess, laceration repairs requiring sutures, nerve blocks (specifically digital nerve blocks), and other minor procedures requiring local anesthesia. The investigators hypothesize that adult and pediatric patients presenting to the ED and undergoing painful minor procedures will report lower pain scores when treated with 0.7 mg/kg intranasal ketamine in addition to standard local anesthesia than patients who receive a volume-based dose of saline solution with standard local anesthesia (control). Additionally, the investigators hypothesize that patients in the treatment cohort will report few side-effects as measured by the Richmond Agitation Sedation Scale (RASS)(i.e., for adult patients) or University of Michigan Sedation Scale (UMSS) (i.e., for pediatric patients). The minor procedures listed above typically require the use of local anesthesia but do not typically require intravenous access. Thus, the use of intranasal ketamine instead of intravenous analgesia minimizes the changes that would be made to the current standard of carrying out these procedures.
In order to avoid a potential confounder of variation in baseline pain severity of the different procedures, only patients undergoing minor procedures that have a similar pain profile will be randomized. Additional aims of the study include decreasing perceived agitation using RASS or UMSS. Collecting data on pain and total discomfort using the NRS-100 point pain scale will provide a unidimensional measurement of patients' subjective interpretation of their pain. The investigators hope to demonstrate that using ketamine at 0.7 mg/kg for associated pain during minor procedures is efficacious and minimizes adverse side effects of ketamine.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 108 is above the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Loyola University is the lead sponsor of 134 studies on the registry; 15 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 23 (88%) have results posted.
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Exclusion Criteria:
Participants assigned to this arm will receive intranasal ketamine administered at 0.7mg/kg along with normal lidocaine local sedation
Drug: Ketamine
Participants assigned to this arm will receive volume-based dose of intranasal saline administered along with normal lidocaine local sedation
Other: Saline
Ketamine is an N-methyl-D aspartate receptor agonist
Intranasal saline flushes pollen, dust, and other debris from nasal passages. It also removes excess mucus and adds moisture
Also known as: Placebo
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
Time frame: 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
Time frame: 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
Time frame: 60 minutes
Immediate agitation
For adults, agitation will be measured using the Richmond Agitation Sedation Scale (RASS) which is a 10-point scale (range: -5 to +4), where higher scores reflect greater agitation.
Time frame: 15 minutes
Acute agitation
For adults, agitation will be measured using the Richmond Agitation Sedation Scale (RASS) which is a 10-point scale (range: -5 to +4), where higher scores reflect greater agitation.
Time frame: 30 minutes
Delayed agitation
For adults, agitation will be measured using the Richmond Agitation Sedation Scale (RASS) which is a 10-point scale (range: -5 to +4), where higher scores reflect greater agitation.
Time frame: 60 minutes
Immediate alertness
For pediatric patients, agitation will be measured using the University of Michigan Sedation Scale (UMSS) which assesses the level of alertness on a five-point scale ranging from 0 (awake and alert) to 4 (unarousable).
Time frame: 15 minutes
Acute alertness
For pediatric patients, agitation will be measured using the University of Michigan Sedation Scale (UMSS) which assesses the level of alertness on a five-point scale ranging from 0 (awake and alert) to 4 (unarousable).
Time frame: 30 minutes
Delayed alertness
For pediatric patients, agitation will be measured using the University of Michigan Sedation Scale (UMSS) which assesses the level of alertness on a five-point scale ranging from 0 (awake and alert) to 4 (unarousable).
Time frame: 60 minutes
Plan to share: No — There is no plan to share individual participant data with other researchers
Started May 2022 (actual). Primary completion is estimated for May 2028, 72 months after the start.
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Studies of the drug tested here: Ketamine