SedationEarly Phase 1NCT07040163
Evaluation of Ketamine/Midazolam Sedation vs. Fentanyl/Midazolam Sedation for Image-Guided Percutaneous Procedures in Interventional Radiology
A Early Phase 1 study testing ketamine, fentanyl and Midazolam in people with Sedation and Interventional Radiology, run by CAMC Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sedation, Interventional Radiology, Biopsy
- What is being tested?
- ketamine, fentanyl and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2025to Jun 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Hypotension or respiratory failure precluding fentanyl sedation
- Uncontrolled hypertension precluding ketamine sedation
- Condition for which hypertension would be a concern
- Schizophrenia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Single-Blinded Randomized Study of Ketamine/Midazolam Sedation vs. Fentanyl/Midazolam Sedation for Image-Guided Percutaneous Procedures in Interventional Radiology
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.
Read the detailed description
This project will provide the following major innovations:
- Improve patient experience and satisfaction: Prospective demonstration that ketamine/midazolam results in decreased peri-procedure pain scores and increased satisfaction scores would justify the use of deep sedation in IR and potentially benefit thousands of patients undergoing painful procedures in IR units across the country.
- Demonstrate the safety and feasibility of ketamine/midazolam sedation administered by IR providers: Showing that performing IR procedures with ketamine/midazolam is as safe or safer than performing the same procedures with fentanyl/midazolam will increase the scope of cases that IR providers can perform without the direct assistance of anesthesia providers and need for recovery in post-anesthesia care units.
- Provide high level data to justify creation of societal guidelines: One barrier to IR physicians performing deep sedation may be an inability to obtain hospital privileges. Emergency medicine physicians have created societal guidelines to describe the use of deep sedation, enabling successful credentialing. Publishing high quality studies showing safety and efficacy would provide a framework for IR-specific practice guidelines.
The aims of the study are as follows:
Aim 1: Prospectively compare pain and satisfaction scores in patients undergoing IR procedures with either fentanyl/midazolam or ketamine/midazolam. Patients undergoing image-guided biopsy and drainage procedures will be randomized to receive fentanyl/midazolam or ketamine/midazolam. Patients' pain will be rated using the validated 10-point Numeric Rating Scale before, during and after the procedure, and be given questionnaires based on validated anesthesia satisfaction surveys after the procedure to assess their perception of the sedation regimen. Patient groups will be compared in terms of differences on pain scores and the satisfaction survey using two-tailed Mann-Whitney tests.
Aim 2: Prospectively compare the safety of using fentanyl/midazolam or ketamine/midazolam for sedation during IR procedures. Patient groups will be compared in terms of procedure-related adverse events (e.g., hemorrhage, pneumothorax) and sedation-related adverse events (e.g., respiratory compromise) using Fisher's exact tests.
- Conditions
- Sedation, Interventional Radiology, Biopsy, Drainage Procedure
- Keywords
- ketamine, interventional radiology, fentanyl, sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
This is the experimental intervention to be used as an alternative sedation method to the other comparator intervention (fentanyl).
fentanylDrug
This is the traditional (comparator) intervention used in interventional radiology procedure sedation.
MidazolamDrug
Adjuvant administered in combination with either fentanyl (comparator) or ketamine (experimental).
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Sedation | Experimental | This arm will utilize a ketamine/midazolam combination sedation for interventional radiology procedures instead of fentanyl/midazolam combination sedation. Receives: Drug: ketamine; Drug: Midazolam |
| Fentanyl Sedation | Active comparator | This arm of the study will receive the traditional fentanyl/midazolam combination sedation for the interventional radiology procedure. Receives: Drug: fentanyl; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) pain score
The patient will be asked to assess their pain based on the NRS 11-point pain score system from 0 (no pain) to 10 (worst possible pain) at three different time points: before the procedure (pre-procedure), during the procedure (intra-procedure), and after the procedure (peri-procedure). If the patient does not recall the procedure, it will be marked as a "0" for the intra-procedural portion.
Measured: Baseline, peri-procedure, peri-anesthetic (minimum 2 hours post-procedure)
Secondary outcomes (2)
Procedure-related Adverse Events and Vital Signs
Oxygen saturation and blood pressure will be measured before and during the procedure. Adverse events, such as MET call, code call, intubation, reversal agent, pneumothorax, hemorrhage, and death, will be recorded.
Measured: Start of the procedure, end of the procedure, and when the patient fully recovers from anesthesia well-enough to be discharged from the recovery room. These events (enrollment, procedure, and anesthesia recovery) all occur within the same day.
Patient's Opinion Survey: Adequacy of Sedation Care
The Adequacy of Sedation Care survey form (a modified version of the Heidelberg peri-anesthetic questionnaire) consists of 18 questions relating to the patient's opinion of the sedation they received. Questions 1-16 are rated on a scale from 1 (Strongly Disagree) to 4 (Strongly Agree). Question 17 asks if the patient would, in the future, have "more sedation," "same sedation," or "less sedation." Question 18 asks the patient to rate their level of pain on a scale from 0 (no pain) to 10 (worst possible pain). It will be administered after the patient has fully recovered from anesthesia, at a minimum of 2 hours post-surgery, well-enough to be discharged from the recovery room.
Measured: Peri-anesthetic (minimum of 2 hours post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start7 Mar 2025
- Primary completion13 Feb 2026
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this prospective, single-center, single-blind randomized study, all patients 18 years of age and older undergoing image-guided lung and bone biopsy and percutaneous drainage who are eligible for moderate or deep sedation will be recruited. Subjects will be randomized to receive fentanyl/midazolam or ketamine/midazolam using SPSS. Patients will be unaware of which regimen they ultimately receive.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Sarah & Pauline Maier Foundation, Inc., Radiological Society of North America, Society of Interventional Radiology Foundation
- Responsible party
- Sponsor
- Investigators
- Amy R Deipolyi, M.D., Ph.D., Principal investigator, CAMC Department of Interventional Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040163
- Sponsor's protocol ID
- 24-1149
- Status last verified
- Jun 2025
- First submitted
- 29 May 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The data obtained from this study relies on patient opinion surveys and pain scales. At this time, individual patient data will not be shared. Data that is relevant to the outcomes of the study, as well as detailed statistical methods, will be included in publications that use the data gathered from this trial.
Publications
Sener S, Eken C, Schultz CH, Serinken M, Ozsarac M. Ketamine with and without midazolam for emergency department sedation in adults: a randomized controlled trial. Ann Emerg Med. 2011 Feb;57(2):109-114.e2. doi: 10.1016/j.annemergmed.2010.09.010.
PubMed 20970888Radvansky BM, Shah K, Parikh A, Sifonios AN, Le V, Eloy JD. Role of ketamine in acute postoperative pain management: a narrative review. Biomed Res Int. 2015;2015:749837. doi: 10.1155/2015/749837. Epub 2015 Oct 1.
PubMed 26495312Lemos JN, Lemos LDCN, Solla DJF, Lemos DDCN, Modolo NSP. Patient satisfaction in ambulatory anesthesia assessed by the Heidelberg Peri-anaesthetic Questionnaire: a cross-sectional study. Braz J Anesthesiol. 2023 May-Jun;73(3):258-266. doi: 10.1016/j.bjane.2021.12.003. Epub 2021 Dec 25.
PubMed 34963617Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
PubMed 22588748Cashman JN, Ng L. The management of peri- and postprocedural pain in interventional radiology: a narrative review. Pain Manag. 2017 Nov;7(6):523-535. doi: 10.2217/pmt-2017-0024. Epub 2017 Nov 10.
PubMed 29125398Sutley SH, Kraut RA. A comparison of transcutaneous PO2 in patients sedated with diazepam-fentanyl or midazolam-fentanyl. Anesth Prog. 1989 May-Jun;36(3):93-7.
PubMed 2638156Boggs SD, Barnett SR, Urman RD. The future of nonoperating room anesthesia in the 21st century: emphasis on quality and safety. Curr Opin Anaesthesiol. 2017 Dec;30(6):644-651. doi: 10.1097/ACO.0000000000000528.
PubMed 28984638Deipolyi AR, Bommineni M, Ahmad A, Belcher A, Dugan B, Mattox E, Korona MV, Cooper S, Dean S. Ketamine Plus Midazolam versus Fentanyl Plus Midazolam for Sedation and Analgesia during Image-guided Procedures in Interventional Radiology: Randomized Clinical Trial. Radiology. 2026 Sep;320(3):e260671. doi: 10.1148/radiol.260671.
PubMed 42708854
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single-Blinded Randomized Study of Ketamine/Midazolam Sedation vs. Fentanyl/Midazolam Sedation for Image-Guided Percutaneous Procedures in Interventional Radiology
- ClinicalTrials.gov ID
- NCT07040163
- Acronym / sponsor ID
- 24-1149
- Conditions
- Sedation, Interventional Radiology, Biopsy, Drainage Procedure
- Keywords
- ketamine, interventional radiology, fentanyl, sedation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 276 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Collaborators
- Sarah & Pauline Maier Foundation, Inc., Radiological Society of North America, Society of Interventional Radiology Foundation
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This project will provide the following major innovations:
- Improve patient experience and satisfaction: Prospective demonstration that ketamine/midazolam results in decreased peri-procedure pain scores and increased satisfaction scores would justify the use of deep sedation in IR and potentially benefit thousands of patients undergoing painful procedures in IR units across the country.
- Demonstrate the safety and feasibility of ketamine/midazolam sedation administered by IR providers: Showing that performing IR procedures with ketamine/midazolam is as safe or safer than performing the same procedures with fentanyl/midazolam will increase the scope of cases that IR providers can perform without the direct assistance of anesthesia providers and need for recovery in post-anesthesia care units.
- Provide high level data to justify creation of societal guidelines: One barrier to IR physicians performing deep sedation may be an inability to obtain hospital privileges. Emergency medicine physicians have created societal guidelines to describe the use of deep sedation, enabling successful credentialing. Publishing high quality studies showing safety and efficacy would provide a framework for IR-specific practice guidelines.
The aims of the study are as follows:
Aim 1: Prospectively compare pain and satisfaction scores in patients undergoing IR procedures with either fentanyl/midazolam or ketamine/midazolam. Patients undergoing image-guided biopsy and drainage procedures will be randomized to receive fentanyl/midazolam or ketamine/midazolam. Patients' pain will be rated using the validated 10-point Numeric Rating Scale before, during and after the procedure, and be given questionnaires based on validated anesthesia satisfaction surveys after the procedure to assess their perception of the sedation regimen. Patient groups will be compared in terms of differences on pain scores and the satisfaction survey using two-tailed Mann-Whitney tests.
Aim 2: Prospectively compare the safety of using fentanyl/midazolam or ketamine/midazolam for sedation during IR procedures. Patient groups will be compared in terms of procedure-related adverse events (e.g., hemorrhage, pneumothorax) and sedation-related adverse events (e.g., respiratory compromise) using Fisher's exact tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In this prospective, single-center, single-blind randomized study, all patients 18 years of age and older undergoing image-guided lung and bone biopsy and percutaneous drainage who are eligible for moderate or deep sedation will be recruited. Subjects will be randomized to receive fentanyl/midazolam or ketamine/midazolam using SPSS. Patients will be unaware of which regimen they ultimately receive.
| Arm | Type | Receives |
|---|---|---|
| Ketamine Sedation | Experimental | Drug: ketamine, Drug: MidazolamThis arm will utilize a ketamine/midazolam combination sedation for interventional radiology procedures instead of fentanyl/midazolam combination sedation. |
| Fentanyl Sedation | Active comparator | Drug: fentanyl, Drug: MidazolamThis arm of the study will receive the traditional fentanyl/midazolam combination sedation for the interventional radiology procedure. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Pregnant/lactating
- Incarceration
- Currently taking an opioid agonist/antagonist
- Food consumed in past 6-8 hours
- Allergies to drugs used in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketamineThis is the experimental intervention to be used as an alternative sedation method to the other comparator intervention (fentanyl). | Drug | Ketamine Sedation |
| fentanylThis is the traditional (comparator) intervention used in interventional radiology procedure sedation. | Drug | Fentanyl Sedation |
| MidazolamAdjuvant administered in combination with either fentanyl (comparator) or ketamine (experimental). | Drug | Fentanyl Sedation, Ketamine Sedation |
Primary outcome
Numeric Rating Scale (NRS) pain score
Time frame: Baseline, peri-procedure, peri-anesthetic (minimum 2 hours post-procedure)
The patient will be asked to assess their pain based on the NRS 11-point pain score system from 0 (no pain) to 10 (worst possible pain) at three different time points: before the procedure (pre-procedure), during the procedure (intra-procedure), and after the procedure (peri-procedure). If the patient does not recall the procedure, it will be marked as a "0" for the intra-procedural portion.
2 secondary outcomes
Procedure-related Adverse Events and Vital Signs
Time frame: Start of the procedure, end of the procedure, and when the patient fully recovers from anesthesia well-enough to be discharged from the recovery room. These events (enrollment, procedure, and anesthesia recovery) all occur within the same day.
Patient's Opinion Survey: Adequacy of Sedation Care
Time frame: Peri-anesthetic (minimum of 2 hours post-surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 20970888Sener S, Eken C, Schultz CH, Serinken M, Ozsarac M. Ketamine with and without midazolam for emergency department sedation in adults: a randomized controlled trial. Ann Emerg Med. 2011 Feb;57(2):109-114.e2. doi: 10.1016/j.annemergmed.2010.09.010.
- Background: PubMed 26495312Radvansky BM, Shah K, Parikh A, Sifonios AN, Le V, Eloy JD. Role of ketamine in acute postoperative pain management: a narrative review. Biomed Res Int. 2015;2015:749837. doi: 10.1155/2015/749837. Epub 2015 Oct 1.
- Background: PubMed 34963617Lemos JN, Lemos LDCN, Solla DJF, Lemos DDCN, Modolo NSP. Patient satisfaction in ambulatory anesthesia assessed by the Heidelberg Peri-anaesthetic Questionnaire: a cross-sectional study. Braz J Anesthesiol. 2023 May-Jun;73(3):258-266. doi: 10.1016/j.bjane.2021.12.003. Epub 2021 Dec 25.
- Background: PubMed 22588748Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
- Background: PubMed 29125398Cashman JN, Ng L. The management of peri- and postprocedural pain in interventional radiology: a narrative review. Pain Manag. 2017 Nov;7(6):523-535. doi: 10.2217/pmt-2017-0024. Epub 2017 Nov 10.
- Background: PubMed 2638156Sutley SH, Kraut RA. A comparison of transcutaneous PO2 in patients sedated with diazepam-fentanyl or midazolam-fentanyl. Anesth Prog. 1989 May-Jun;36(3):93-7.
- Background: PubMed 28984638Boggs SD, Barnett SR, Urman RD. The future of nonoperating room anesthesia in the 21st century: emphasis on quality and safety. Curr Opin Anaesthesiol. 2017 Dec;30(6):644-651. doi: 10.1097/ACO.0000000000000528.
- Derived from this study: PubMed 42708854Deipolyi AR, Bommineni M, Ahmad A, Belcher A, Dugan B, Mattox E, Korona MV, Cooper S, Dean S. Ketamine Plus Midazolam versus Fentanyl Plus Midazolam for Sedation and Analgesia during Image-guided Procedures in Interventional Radiology: Randomized Clinical Trial. Radiology. 2026 Sep;320(3):e260671. doi: 10.1148/radiol.260671.
- Individual participant dataSharing planned: No. The data obtained from this study relies on patient opinion surveys and pain scales. At this time, individual patient data will not be shared. Data that is relevant to the outcomes of the study, as well as detailed statistical methods, will be included in publications that use the data gathered from this trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy R Deipolyi, M.D., Ph.D. principal investigator
CAMC Department of Interventional Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ketamine, fentanyl and Midazolam in people with Sedation and Interventional Radiology, run by CAMC Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) pain score (time frame: Baseline, peri-procedure, peri-anesthetic (minimum 2 hours post-procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07040163, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.