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

Trial Summary

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.

How does ketamine differ from other treatments for procedural pain?

Ketamine is unique for procedural pain because it works by blocking NMDA receptors in the brain, which are involved in pain transmission, offering a different mechanism compared to traditional painkillers like opioids. It can be administered intravenously, providing rapid pain relief, and is often used when other pain management strategies are ineffective. ^{1 2 3 4 5}

What is the purpose of this trial?

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

Research Team

Trent Reed, DO

Principal Investigator

Loyola University

Eligibility Criteria

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

I am having a minor procedure in the emergency department.

Weight not to exceed 115kg

Exclusion Criteria

Altered Mental Status

Allergy to Ketamine

Pregnancy

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Percutaneous kyphoplasty treatment evaluation for patients with Kümmell disease based on a two-year follow-up. [2020]

2. China pubmed.ncbi.nlm.nih.gov

[Treatment of senile osteoporotic vertebral compression fractures with percutaneous kyphoplasty under local anesthesia]. [2014]

3. United States 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Risks and benefits of percutaneous vertebroplasty or kyphoplasty in the management of osteoporotic vertebral fractures. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Analysis of percutaneous kyphoplasty or short-segmental fixation combined with vertebroplasty in the treatment of Kummell disease. [2020]