drugset / Trial / NCT05803096
Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain
Phase 4
Completed
143 enrolled
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital · collab
RandomizedParallel-groupDouble-blindSupportive care
Summary
Transrectal prostate biopsy is a commonly performed ambulatory procedure for diagnosing prostate cancer. Prostate biopsy are associated with pain or anxiety. Nitrous oxide (or laughing gas) is a well-known inhaled anesthetic which is frequently used in dental offices and for pediatric procedures to alleviate a patient's anxiety and pain. This study seeks to determine whether administration of nitrous oxide at the time of prostate biopsy will improve a patient's experience of care.
Timeline
- Start
- 2021-12-12
- Primary completion
- 2022-09-02
- Completion
- 2022-09-09
Publications
- Background Loeb S, Carter HB, Berndt SI, Ricker W, Schaeffer EM. Complications after prostate biopsy: data from SEER-Medicare. J Urol. 2011 Nov;186(5):1830-4. doi: 10.1016/j.juro.2011.06.057. Epub 2011 Sep 23.
- Background Rosario DJ, Lane JA, Metcalfe C, Donovan JL, Doble A, Goodwin L, Davis M, Catto JW, Avery K, Neal DE, Hamdy FC. Short term outcomes of prostate biopsy in men tested for cancer by prostate specific antigen: prospective evaluation within ProtecT study. BMJ. 2012 Jan 9;344:d7894. doi: 10.1136/bmj.d7894.
- Background Jastak JT, Donaldson D. Nitrous oxide. Anesth Prog. 1991 Jul-Oct;38(4-5):142-53. No abstract available.
- Background Practice Guidelines for Moderate Procedural Sedation and Analgesia 2018: A Report by the American Society of Anesthesiologists Task Force on Moderate Procedural Sedation and Analgesia, the American Association of Oral and Maxillofacial Surgeons, American College of Radiology, American Dental Association, American Society of Dentist Anesthesiologists, and Society of Interventional Radiology. Anesthesiology. 2018 Mar;128(3):437-479. doi: 10.1097/ALN.0000000000002043. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Nitrous Oxide | Other / unclassified | — | Inhaled |