Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain
Condition: Prostate Disease; Malignancy; Benign Prostatic Hyperplasia; Prostate Cancer; Prostate Adenocarcinoma; Anxiety and Fear; Pain
MeSH terms: Prostatic Neoplasms; Prostatic Hyperplasia; Prostatic Diseases; Hyperplasia; Anxiety Disorders
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Nitrous oxide is a well-tolerated inhaled anesthetic that has been used for decades in
      pediatric and adult populations and is largely viewed as effective and safe. In addition to
      analgesic effect, nitrous oxide also produces a dissociative euphoria and amnesia that could
      potentially improve patients' anxiety and experience of cancer care. When used as a single
      agent at concentrations ≤50%, the American Society of Anesthesiologists (ASA) classifies
      nitrous oxide as Minimal Sedation, producing a state in which a patient responds normally to
      verbal commands, maintains airway reflexes, and spontaneous ventilation. Over the past
      several decades nitrous oxide has become less common due to concerns of nitrous oxide
      environmental exposure to the care team. There are now Federal Drug Administration
      (FDA)-approved systems that allow patient self-administered nitrous oxide (SANO), and
      importantly, include a scavenger system to eliminate exhaled environmental nitrous oxide.
      These systems are rapidly being adopted throughout the United States in Urology practices,
      but to date, there have been no studies evaluating patient outcomes and possible risks with
      the adjunct use of SANO. This study is a prospective, randomized, controlled trial to assess
      patient perceived pain and anxiety related to prostate needle biopsy with or without SANO,
      and the frequency of complications associated with SANO. A secondary aim will be to
      demonstrate that the SANO at the time of prostate biopsy does not significantly increase
      burden on Urologist productivity, nor increase the difficulty of operator ease in performing
      the prostate needle biopsy.
    

Intervention name(s): Self-Administered Nitrous Oxide; Oxygen
Intervention type(s): Drug; Other
Intervention description(s): Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.; Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.
Other intervention name(s): nitrous oxide
Intervention MeSH terms: Nitrous Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized 1:1 to either SANO (treatment) or oxygen (placebo control) after completion of baseline assessment. The results of the randomization will not be disclosed to patients as part of the study (patient-blinded).
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: prostate biopsy; nitrous oxide; prostate cancer; ambulatory; patient experience of care