Ketamine for Procedural Pain

(INK-MP Trial)

Overseen By Shannon Lovett, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Loyola University

Disqualifiers: Altered mental status, Pregnancy, Seizures, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Immediate (within 1 day)

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if ketamine, a type of pain relief, can reduce pain during minor procedures in the emergency department. Participants will receive either intranasal ketamine or a placebo (a harmless substance with no effect). Researchers seek to find out if those receiving ketamine experience less pain and fewer side effects, such as agitation or drowsiness. This trial may suit individuals undergoing a simple procedure in the emergency department who weigh less than 115 kg. As a Phase 4 trial, ketamine is already FDA-approved and proven effective, and this research helps to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for ketamine?

Research has shown that intranasal ketamine is generally safe for people. In earlier studies, participants experienced only mild side effects, which were not serious. Another study found that most people tolerated intranasal ketamine well, without major problems. Notably, this treatment has been successfully used for both adults and children during minor procedures. Overall, these findings suggest that intranasal ketamine effectively reduces pain without causing significant side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for procedural pain, which often rely on opioids or non-steroidal anti-inflammatory drugs (NSAIDs), intranasal ketamine offers a novel approach by using a different mechanism of action. Ketamine works by blocking NMDA receptors in the brain, which can help in reducing pain and making it an exciting alternative, especially for those who may not tolerate traditional pain medications well. Additionally, the intranasal delivery method is quick and easy, potentially providing faster pain relief without the need for injections or oral medications. Researchers are particularly interested in ketamine's potential to manage pain effectively with fewer side effects, such as addiction or gastrointestinal issues, often associated with opioids and NSAIDs.

What evidence suggests that ketamine might be an effective treatment for procedural pain?

Research has shown that ketamine, when used as a nasal spray, can help manage sudden pain. One study found it provides pain relief similar to traditional IV painkillers. Another study found that nasal ketamine significantly reduced pain in children during medical procedures. A review of several studies noted that nasal ketamine can calm patients enough to perform various medical procedures. In this trial, participants in one arm will receive intranasal ketamine, which might help reduce pain and discomfort during minor procedures in the emergency room. ^{1 5 6 7 8}

Who Is on the Research Team?

Trent Reed, DO

Principal Investigator

Loyola University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Weight not to exceed 115kg

I am having a minor procedure in the emergency department.

Exclusion Criteria

Altered Mental Status

Allergy to Ketamine

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 0.7 mg/kg intranasal ketamine or intranasal saline along with standard local anesthesia during minor procedures in the ED

Immediate (within 1 day)

1 visit (in-person)

Follow-up

Participants are monitored for pain and agitation using various scales immediately and at delayed intervals post-procedure

1-2 hours

1 visit (in-person)

Data Analysis

Data on pain and agitation are collected and analyzed to assess the efficacy of intranasal ketamine

4-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ketamine

Trial Overview

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.

How Is the Trial Designed?

Group I: Intranasal Ketamine Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Loyola University

Lead Sponsor

Trials

161

Recruited

31,400+

Published Research Related to This Trial

In a study of 150 patients with osteoporotic vertebral compression fractures, the addition of a local anesthetic and steroid injection during percutaneous kyphoplasty significantly reduced pain and disability in the short term compared to PKP alone, as measured by the visual analog scale (VAS) and Oswestry disability index (ODI) at 1 day, 3 days, 1 week, and 1 month post-surgery.

While the benefits of the local anesthetic and steroid injection were evident in the short term, by 3 months post-operation, there were no significant differences in pain levels or disability between the two groups, indicating that the injection may primarily enhance early recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Anesthetic and Steroid Injection to Relieve the Distal Lumbosacral Pain in Osteoporotic Vertebral Compression Fractures of Patients Treated with Kyphoplasty. Lin, F., Zhang, Y., Wu, T., et al.[2022]

Percutaneous vertebroplasty (VP) and balloon kyphoplasty (KP) procedures provide short-term pain relief for vertebral fractures, but randomized controlled trials show mixed results regarding their long-term benefits and safety.

Both VP and KP are associated with an increased risk of new vertebral fractures, particularly adjacent to the treated site, highlighting the need for careful patient selection and the initiation of osteoporosis therapy after a fracture occurs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks and benefits of percutaneous vertebroplasty or kyphoplasty in the management of osteoporotic vertebral fractures. Lamy, O., Uebelhart, B., Aubry-Rozier, B.[2021]

Both percutaneous kyphoplasty (PKP) and short-segment internal fixation combined with vertebroplasty (SSF + VP) are safe and effective treatments for Kummell disease in patients without neurological deficits, based on an analysis of three retrospective studies.

PKP is particularly advantageous as it significantly reduces operation time and blood loss compared to SSF + VP, making it a preferable option for treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of percutaneous kyphoplasty or short-segmental fixation combined with vertebroplasty in the treatment of Kummell disease. Lu, W., Wang, L., Xie, C., et al.[2020]

Percutaneous kyphoplasty (PKP) significantly reduced pain levels in patients with Kümmell disease, as shown by a decrease in the Visual Analog Scale (VAS) scores from 7.00 pre-surgery to 3.14 at 2 years post-surgery, indicating its efficacy as a treatment.

The study found a positive correlation between the volume of cement injected during PKP and the level of pain relief, suggesting that careful dosing of cement may enhance treatment outcomes, while the procedure was deemed safe with no severe complications reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous kyphoplasty treatment evaluation for patients with Kümmell disease based on a two-year follow-up. Xia, YH., Chen, F., Zhang, L., et al.[2020]

Percutaneous kyphoplasty (PKP) is an effective treatment for senile osteoporotic vertebral compression fractures, significantly reducing pain (VAS score decreased from 7.9 to 3.0) and improving vertebral body height and Cobb angle over an average follow-up of 34.2 months.

While PKP is minimally invasive and generally safe, complications such as bone cement leakage occurred in 17.8% of cases, highlighting the importance of careful patient selection and surgical technique to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of senile osteoporotic vertebral compression fractures with percutaneous kyphoplasty under local anesthesia]. Ru, XL., Jiang, ZH., Song, BS., et al.[2014]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8432265/

Efficacy and Safety of Intranasal Ketamine for Acute Pain ...

Our results suggest that IN ketamine is non-inferior to IV analgesics and may have a role in acute pain management among adults in the ED.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5103427/

Intranasal ketamine for acute traumatic pain in the ...

The 3 study groups showed a highly significant, similar maximal pain reduction of 56 ± 26 mm for IN Ketamine, and 59 ± 22 and 48 ± 30 for IV MO ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0735675723000505?dgcid=rss_sd_all

Intranasal ketamine for procedural sedation in children

Primary outcome. Procedural sedation using 6 mg/kg of intranasal ketamine was effective in 18 (60%; 95% CI, 42% to 78%) patients. In 5 (17%) patients, the ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06139380

Study Details | NCT06139380 | Intranasal Ketamine ...

Intranasal administration of Ketamine would reduce the intramuscular pain of ketamine injection in children who undergo procedural sedation and analgesia in ...

5.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0173253

Intranasal ketamine for procedural sedation and analgesia in ...

In this systematic review of seven studies, IN ketamine produced sedation adequate enough to perform the procedure under study. However, the superiority of IN ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1366007107001672

Safety and efficacy of intranasal ketamine for acute ...

The primary outcome was median pain rating reduction at 30 minutes. Secondary outcomes were pain rating reduction at 15 and 60 minutes, subjective ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11257024/

Safety and Efficacy of Intranasal Ketamine for Minor Pediatric ...

It can be concluded that the use of IK for procedural sedation among pediatric patients is safe and effective.

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06284473

Ketamine as a Supplement to Local Anesthesia for Minor ...

Several randomized clinical studies have shown that ketamine is a comparable pain relief medication to opioid analgesics in both acute pain and traumatic ...