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| Name | Class |
|---|---|
| Sarah & Pauline Maier Foundation, Inc. | OTHER |
| Radiological Society of North America | OTHER |
| Society of Interventional Radiology Foundation | OTHER |
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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.
This project will provide the following major innovations:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine Sedation | Experimental | This arm will utilize a ketamine/midazolam combination sedation for interventional radiology procedures instead of fentanyl/midazolam combination sedation. |
|
| Fentanyl Sedation | Active Comparator | This arm of the study will receive the traditional fentanyl/midazolam combination sedation for the interventional radiology procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketamine | Drug | This is the experimental intervention to be used as an alternative sedation method to the other comparator intervention (fentanyl). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, peri-procedure, peri-anesthetic (minimum 2 hours post-procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy R Deipolyi, M.D., Ph.D. | CAMC Department of Interventional Radiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAMC Memorial | Charleston | West Virginia | 25304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20970888 | Background | 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. | |
| 26495312 | Background | Radvansky 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. |
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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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 18, 2026 | |
| Reset | Apr 6, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2025 |
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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.
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| fentanyl | Drug | This is the traditional (comparator) intervention used in interventional radiology procedure sedation. |
|
| Midazolam | Drug | Adjuvant administered in combination with either fentanyl (comparator) or ketamine (experimental). |
|
| 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. | Peri-anesthetic (minimum of 2 hours post-surgery) |
| 34963617 | Background | Lemos 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. |
| 22588748 | Background | Hawker 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. |
| 29125398 | Background | Cashman 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. |
| 2638156 | Background | Sutley 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. |
| 28984638 | Background | Boggs 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. |
| May 19, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 7, 2025 | May 19, 2025 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 18, 2026 | Apr 6, 2026 |
| ID | Term |
|---|---|
| D007649 | Ketamine |
| D005283 | Fentanyl |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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