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Intranasal Ketamine for Procedural Pain (INK-MP Trial)

Phase 4

Recruiting

Led By Trent Reed, DO

Research Sponsored by Loyola University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 minutes

Awards & highlights

INK-MP Trial Summary

"This trial is testing the use of intranasal ketamine for pain relief during minor procedures in the Emergency Department. Patients will be divided into two groups: one receiving ketamine and the other a saline

Who is the study for?

This trial is for adults and children aged 7 to under 70 who need minor procedures in the ED that require local anesthesia. Participants must be able to receive intranasal medication and report pain scores. Those with conditions affecting nasal absorption or at risk of adverse reactions from ketamine are excluded.Check my eligibility

What is being tested?

The study tests if a dose of intranasal ketamine (0.7 mg/kg) can better reduce pain during minor procedures compared to an intranasal saline solution, both alongside standard local anesthesia. Pain levels will be measured using specific scales for adults and children.See study design

What are the potential side effects?

Ketamine may cause side effects such as feelings of disorientation, changes in alertness, agitation, nausea, or increased blood pressure. The severity can vary among individuals.

INK-MP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acute pain

Delayed pain

Immediate pain

Secondary outcome measures

Acute agitation

Acute alertness

Delayed agitation

+3 more

INK-MP Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intranasal KetamineExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

2011

Completed Phase 4

~1090

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Loyola UniversityLead Sponsor

156 Previous Clinical Trials

30,826 Total Patients Enrolled

Trent Reed, DOPrincipal InvestigatorLoyola University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction for potential participants in this study, particularly regarding individuals who are 55 years of age or older?

"Eligible participants for this research must be over 7 years of age but under 70 years old."

Answered by AI

What are the eligibility criteria for individuals seeking to participate in this clinical study?

"Individuals aged between 7 and 70 with abscess are eligible to participate in this research study, which aims to enroll approximately 108 participants."

Answered by AI

Are researchers currently seeking participants for this clinical trial?

"According to clinicaltrials.gov, this investigation is currently seeking participants. The trial was initially published on May 25th, 2022 and last revised on February 22nd, 2024."

Answered by AI

What is the current patient population enrolled in this clinical trial?

"Indeed, the details on clinicaltrials.gov indicate that this particular medical trial is actively seeking volunteers. The initial posting of the trial was made on May 25th, 2022, with the most recent update recorded on February 22nd, 2024. Recruitment aims to reach a total of 108 participants from one designated location."

Answered by AI

Has the FDA officially authorized the utilization of intranasal ketamine?

"Based on our assessments at Power, Intranasal Ketamine has been rated a 3 in terms of safety. This classification is due to the trial being classified as Phase 4, indicating that this treatment has gained approval for use."

Answered by AI

Recent research and studies

Annals of Emergency MedicineJournal

Intravenous Subdissociative-dose Ketamine Versus Morphine for Analgesia in the Emergency Department: A Randomized Controlled Trial

Motov, Sergey, Bradley Rockoff, Victor Cohen, Illya Pushkar, Antonios Likourezos, Courtney McKay, Emil Soleyman-Zomalan, Peter Homel, Victoria Terentiev, and Christian Fromm. 2015. “Intravenous Subdissociative-dose Ketamine Versus Morphine for Analgesia in the Emergency Department: A Randomized Controlled Trial”. Annals of Emergency Medicine. Elsevier BV. doi:10.1016/j.annemergmed.2015.03.004.

Academic Emergency MedicineJournal

A Systematic Review and Meta‐analysis of Ketamine as an Alternative to Opioids for Acute Pain in the Emergency Department

Karlow, Nicholas, Charles H. Schlaepfer, Carolyn R. T. Stoll, Michelle Doering, Christopher R. Carpenter, Graham A. Colditz, Sergey Motov, Joshua Miller, and Evan S. Schwarz. 2018. “A Systematic Review and Meta‐analysis of Ketamine as an Alternative to Opioids for Acute Pain in the Emergency Department”. Edited by James Miner. Academic Emergency Medicine. Wiley. doi:10.1111/acem.13502.

clinicaltrials.govStudy

Ketamine as a Supplement to Local Anesthesia for Minor Procedures

Trent Reed 2022. "Ketamine as a Supplement to Local Anesthesia for Minor Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06284473.

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