Evaluation of Ketamine/Midazolam Sedation vs. Fentanyl/Midazolam Sedation for Image-Guided Percutaneous Procedures in Interventional Radiology

NCT07040163 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 24-1149
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sedation; Interventional Radiology; Biopsy; Drainage Procedure

Keywords

ketamine; interventional radiology; fentanyl; sedation

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Procedure-related Adverse Events and Vital Signs

  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

  Peri-anesthetic (minimum of 2 hours post-surgery)

Study Arms (2)

Ketamine Sedation

EXPERIMENTAL

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

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.

Drug: fentanyl; Drug: Midazolam

Interventions

ketamine DRUG

This is the experimental intervention to be used as an alternative sedation method to the other comparator intervention (fentanyl).

Ketamine Sedation

fentanyl DRUG

This is the traditional (comparator) intervention used in interventional radiology procedure sedation.

Fentanyl Sedation

Midazolam DRUG

Adjuvant administered in combination with either fentanyl (comparator) or ketamine (experimental).

Fentanyl Sedation; Ketamine Sedation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CAMC Health System: lead
• Sarah & Pauline Maier Foundation, Inc.: collaborator
• Radiological Society of North America: collaborator
• Society of Interventional Radiology Foundation: collaborator

Study Sites (1)

CAMC Memorial

Charleston, West Virginia, 25304, United States

Location

Related Publications (7)

• 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.

  PMID: 20970888 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.

  PMID: 26495312 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.

  PMID: 34963617 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.

  PMID: 22588748 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.

  PMID: 29125398 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.

  PMID: 2638156 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.

  PMID: 28984638 BACKGROUND

MeSH Terms

Interventions

Ketamine; Fentanyl; Midazolam

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Amy R Deipolyi, M.D., Ph.D.

  CAMC Department of Interventional Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 27, 2025
• Study Start: March 7, 2025
• Primary Completion: February 13, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)