Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain

• Status: Completed
• Trial end date: 2022-09-09
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Brigham and Women's Hospital
• Treatments: Nitrous Oxide

Criteria

Inclusion Criteria:

• Biological male

• Aged 18 to 85 years

• Scheduled for clinically-indicated prostate needle biopsy

• Suitable for nitrous oxide/oxygen with willingness to be randomized to inhaled SANO or inhaled oxygen during the procedure

• Access to an email and computer

Exclusion Criteria:

• Perioral facial hair impeding good mask seal

• Learning disabilities and/or inability to cognitively complete survey questions

• Taken a pre-procedure benzodiazepine or narcotic.

• Has any of the following medical conditions:

1. Inner ear, bariatric or eye surgery within the last 2 weeks,

2. Current emphysematous blebs,

3. Severe B-12 deficiency.

4. Bleomycin chemotherapy within the past year.

5. Class III or higher heart failure.

6. Undergoing novel therapy for prostate cancer