Ketamine vs Fentanyl for Sedation in Interventional Radiology

Overseen By Adam M Belcher, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: CAMC Health System

Must not be taking: Opioid agonists/antagonists

Disqualifiers: Pregnancy, Incarceration, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

252 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of two drug combinations in managing pain during certain interventional radiology procedures, such as biopsies. The goal is to determine if ketamine with midazolam can reduce pain and enhance patient satisfaction compared to the usual combination of fentanyl with midazolam, without increasing side effects. Participants must be scheduled for a bone or lung biopsy or drainage procedure and must be able to safely take ketamine or fentanyl. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking an opioid agonist/antagonist.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that a mix of ketamine and midazolam is safe and effective for calming patients during certain medical procedures. One study found that this combination was not only safe but also preferred by medical staff over the usual mix of fentanyl and midazolam for patient comfort. Another study found that ketamine alone worked as well as the fentanyl and midazolam mix for calming patients and easing pain.

Fentanyl is widely used in hospitals for calming patients and controlling pain, indicating it is generally well-tolerated. However, like all medications, it can have side effects, so monitoring is important while using it.

Both treatments have demonstrated safety in different studies, but it's crucial to consider personal health conditions and consult a doctor before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using ketamine for sedation in interventional radiology because it offers a unique approach compared to traditional fentanyl-based sedation. Unlike fentanyl, which is an opioid and can depress breathing, ketamine works by blocking NMDA receptors in the brain, providing sedation without significantly affecting respiratory function. This makes ketamine potentially safer for patients, especially those with respiratory concerns. Additionally, ketamine can provide pain relief and sedation quickly, which can improve patient comfort during procedures.

What evidence suggests that this trial's treatments could be effective for reducing pain during interventional radiology procedures?

This trial will compare two sedation methods for interventional radiology procedures: one group will receive ketamine with midazolam, and the other will receive fentanyl with midazolam. Research has shown that ketamine with midazolam effectively reduces pain and discomfort during procedures like biopsies and drainage. Studies have found that this combination works as well as fentanyl with midazolam in easing pain during these procedures. Many patients and medical staff prefer ketamine because it enhances comfort. Evidence also suggests that this combination is safe and effective without requiring an anesthesiologist. These findings support the idea that ketamine can improve patient satisfaction during interventional radiology procedures. ^{1 2 3 4 6}

Who Is on the Research Team?

Amy R Deipolyi, M.D., Ph.D.

Principal Investigator

CAMC Department of Interventional Radiology

Are You a Good Fit for This Trial?

This trial is for patients needing biopsies or drainage procedures in interventional radiology, which can be painful. Participants must meet certain health criteria not specified here.

Inclusion Criteria

I am between 18 and 89 years old.

I am scheduled for a biopsy or drainage procedure guided by imaging.

I can be sedated with ketamine or fentanyl.

Exclusion Criteria

High blood pressure would be risky for my condition.

I am currently on a medication that is both an opioid agonist and antagonist.

I am unable to report my pain levels due to mental capacity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure and Sedation

Participants undergo image-guided biopsy and drainage procedures with either fentanyl/midazolam or ketamine/midazolam sedation

1 day

1 visit (in-person)

Immediate Recovery

Participants recover from anesthesia and are monitored for a minimum of 2 hours post-procedure

2-4 hours

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including pain and satisfaction surveys

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fentanyl
• Ketamine

Trial Overview The study compares deep sedation using ketamine/midazolam versus moderate sedation with fentanyl/midazolam to see which is better for pain and patient satisfaction during IR procedures.

How Is the Trial Designed?

Group I: Ketamine Sedation Experimental Treatment 2 Interventions

This arm will utilize a ketamine/midazolam combination sedation for interventional radiology procedures instead of fentanyl/midazolam combination sedation.

Group II: Fentanyl Sedation Active Control 2 Interventions

This arm of the study will receive the traditional fentanyl/midazolam combination sedation for the interventional radiology procedure.

Who Is Running the Clinical Trial?

CAMC Health System

Lead Sponsor

Trials

47

Recruited

8,000+

Sarah & Pauline Maier Foundation, Inc.

Collaborator

Trials

2

Recruited

110+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1546084323000032

Article Safety and Effectiveness of Moderate Sedation With ... Conclusion. The combination of ketamine and midazolam appears to be efficient in delivering sufficient analgesia and moderate sedation during interventional ...

2. jvir.org jvir.org/article/S1051-0443(25)00144-7/abstract

Ketamine/Midazolam versus Fentanyl/Midazolam Sedation ... Compared with fentanyl/midazolam, ketamine/midazolam sedation was superior regarding reduction of patient discomfort and preference by IR staff.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10132230/

Comparing the Safety and Effectiveness of Ketamine ... Our study has shown that ketamine is as effective as midazolam/fentanyl in alleviating procedural pain and providing procedural sedation.

4. trialx.com trialx.com/clinical-trials/listings/299665/evaluation-of-ketaminemidazolam-deep-sedation-vs-fentanylmidazolam-moderate-sedation-for-image-guided-percutaneous-procedures-in-interventional-radiology/

Evaluation of Ketamine/Midazolam Deep Sedation vs. ... Overview. This study aims to reduce pain during interventional radiology (IR) procedures, making the experience better for patients.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051044325001447

Ketamine/Midazolam versus Fentanyl/Midazolam Sedation ... This study suggests that sedation with ketamine/midazolam administered by interventional radiologists without anesthesiology involvement was safe and effective.

6. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.2252011786

Evolution of a Protocol for Ketamine-induced Sedation as ... CONCLUSION: Ketamine-induced sedation may be a safe and effective alternative to general anesthesia for some interventional radiologic procedures in pediatric ...