Evaluation of Ketamine/Midazolam Sedation vs. Fentanyl/Midazolam Sedation for Image-Guided Percut… (NCT07040163) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Evaluation of Ketamine/Midazolam Sedation vs. Fentanyl/Midazolam Sedation for Image-Guided Percutaneous Procedures in Interventional Radiology
United States276 participantsStarted 2025-03-07
Plain-language summary
This study aims to reduce pain during interventional radiology (IR) procedures, making the experience better for patients. Typically, doctors use medications like fentanyl and midazolam for sedation. This research will focus on patients undergoing biopsies and drainage procedures, often associated with significant discomfort. Patients will be randomly assigned to receive either fentanyl/midazolam or ketamine/midazolam combinations for sedation. A coordinator will collect information on pain levels and satisfaction, as well as monitor any extra medications needed and side effects. The investigators hope to find that ketamine helps decrease pain and improves satisfaction compared to fentanyl, without increasing complications.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Planned to undergo image-guided bone biopsy, lung biopsy, or percutaneous drainage
* Eligible to receive ketamine or fentanyl sedation
* Any sex/gender, any race
* Aged 18-89
Exclusion Criteria:
* Pregnant/lactating
* Incarceration
* Currently taking an opioid agonist/antagonist
* Food consumed in past 6-8 hours
* Allergies to drugs used in the study
* Lacks mental capacity for reporting pain scores
* Hypotension or respiratory failure precluding fentanyl sedation
* Uncontrolled hypertension precluding ketamine sedation
* Condition for which hypertension would be a concern
* Schizophrenia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.