Pain, ProceduralPhase 4INK-MPNCT06284473
Ketamine as a Supplement to Local Anesthesia for Minor Procedures
A Phase 4 study testing Ketamine and Saline in people with Pain, Procedural and Minor Laceration, run by Loyola University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 70 years
- Conditions the study is for
- Pain, Procedural, Minor Laceration, Abscess
- What is being tested?
- Ketamine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2022to 31 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergoing Minor Procedure in the ED
- Weight not to exceed 115kg
Who cannot join
- Altered Mental Status
- Pregnancy
- Breastfeeding
- Acute head or eye injury
- Intercranial Hypertension
- Hx of seizures
Show all 12Show fewer
- Hx of chronic pain
- Unstable vital signs
- Allergy to Ketamine
- Hepatic or Renal Insufficiency
- Hx of Psychiatric Illness
- Hx of alcohol/drug abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Shannon Lovett, MD, 8479512936, slovett@lumc.edu
Trent Reed, DO, 708-216-4117, treed1@lumc.edu
About this study
Official title: Intranasal Ketamine as a Supplement to Local Anesthesia to Reduce Pain Associated With Minor Procedures in the Emergency Department
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
Read the detailed description
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.
- Conditions
- Pain, Procedural, Minor Laceration, Abscess
- Being tested
- Ketamine, Saline
- Keywords
- IN Ketamine, Sub-dissociative dose, Minor procedure
- Medical subject headings
- Pain, Procedural, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Ketamine is an N-methyl-D aspartate receptor agonist
SalineOther
Also called Placebo
Intranasal saline flushes pollen, dust, and other debris from nasal passages. It also removes excess mucus and adds moisture
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Ketamine | Experimental | Participants assigned to this arm will receive intranasal ketamine administered at 0.7mg/kg along with normal lidocaine local sedation Receives: 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 Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 60 minutes
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start25 May 2022
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Pain, ProceduralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trent Reed, Loyola University
- Investigators
- Trent Reed, DO, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284473
- Sponsor's protocol ID
- 212154
- Acronym
- INK-MP
- Status last verified
- Sep 2025
- First submitted
- 22 Feb 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers
Publications
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.
PubMed 27829367Beaudoin 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.
PubMed 25377395Motov 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.
PubMed 25817884Zekry 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.
PubMed 27092576Hanna 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.
PubMed 27462225Miller 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.
PubMed 25624076Karlow 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.
PubMed 30019434Optimizing 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.
PubMed 28844277Payne 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.
PubMed 1854389Allen 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.
PubMed 28743507Lee 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.
PubMed 27788221Reynolds 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.
PubMed 27609854Shrestha 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.
PubMed 27006733Reynolds 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.
PubMed 28926159Bouida 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.
PubMed 32080000
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Ketamine as a Supplement to Local Anesthesia to Reduce Pain Associated With Minor Procedures in the Emergency Department
- ClinicalTrials.gov ID
- NCT06284473
- Acronym / sponsor ID
- INK-MP / 212154
- Conditions
- Pain, Procedural, Minor Laceration, Abscess
- Keywords
- IN Ketamine, Sub-dissociative dose, Minor procedure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intranasal Ketamine | Experimental | Drug: KetamineParticipants assigned to this arm will receive intranasal ketamine administered at 0.7mg/kg along with normal lidocaine local sedation |
| Placebo | Placebo comparator | Other: SalineParticipants assigned to this arm will receive volume-based dose of intranasal saline administered along with normal lidocaine local sedation |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing Minor Procedure in the ED
- Weight not to exceed 115kg
Key exclusion criteria (12 listed)
- Altered Mental Status
- Pregnancy
- Breastfeeding
- Acute head or eye injury
- Intercranial Hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineKetamine is an N-methyl-D aspartate receptor agonist | Drug | Intranasal Ketamine |
| SalineAlso: PlaceboIntranasal saline flushes pollen, dust, and other debris from nasal passages. It also removes excess mucus and adds moisture | Other | Placebo |
Primary outcome
Immediate pain
Time frame: 15 minutes
Pain will be measured using the numeric rating scale which is a scale ranging from 0 to 100, where higher values report greater pain
Acute pain
Time frame: 30 minutes
Pain will be measured using the numeric rating scale which is a scale ranging from 0 to 100, where higher values report greater pain
Delayed pain
Time frame: 60 minutes
Pain will be measured using the numeric rating scale which is a scale ranging from 0 to 100, where higher values report greater pain
6 secondary outcomes
Immediate agitation
Time frame: 15 minutes
Acute agitation
Time frame: 30 minutes
Delayed agitation
Time frame: 60 minutes
Immediate alertness
Time frame: 15 minutes
Acute alertness
Time frame: 30 minutes
Delayed alertness
Time frame: 60 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background: PubMed 27829367Shimonovich 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.
- Background: PubMed 25377395Beaudoin 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.
- Background: PubMed 25817884Motov 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.
- Background: PubMed 27092576Zekry 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.
- Background: PubMed 27462225Hanna 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.
- Background: PubMed 25624076Miller 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.
- Background: PubMed 30019434Karlow 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.
- Background: PubMed 28844277Optimizing 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.
- Background: PubMed 1854389Payne 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.
- Background: PubMed 28743507Allen 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.
- Background: PubMed 27788221Lee 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.
- Background: PubMed 27609854Reynolds 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trent Reed, DO principal investigator
Loyola University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Saline in people with Pain, Procedural and Minor Laceration, run by Loyola University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shannon Lovett, MD (708-327-2549, slovett@lumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate pain (time frame: 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06284473, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.