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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
Must not have
Acute head or eye injury
Intracranial Hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes
Awards & highlights
Drug Has Already Been Approved
Pivotal 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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have recently had a head or eye injury.
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I have high pressure inside my skull.
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My vital signs are not stable.
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I have liver or kidney problems.
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I have a history of seizures.
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I have a long-term history of chronic pain.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acute pain
Delayed pain
Immediate pain
Secondary study objectives
Acute agitation
Acute alertness
Delayed agitation
+3 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~1120

Find a Location

Who is running the clinical trial?

Loyola UniversityLead Sponsor
160 Previous Clinical Trials
31,311 Total Patients Enrolled
Trent Reed, DOPrincipal InvestigatorLoyola University
~18 spots leftby May 2025
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