Phase 4
N=133
Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain
Prostate Disease · Malignancy · Benign Prostatic Hyperplasia · Prostate Cancer · Prostate Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT05803096 ↗Enrolled (actual)
133
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Post-biopsy Pain (VAS-P) — 1; 1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Self-Administered Nitrous Oxide (Drug); Oxygen (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-biopsy Pain (VAS-P) |
1; 1 | — |
| PRIMARY Post-biopsy Anxiety (VAS-A) |
0; 1 | — |
| PRIMARY Post-biopsy Anxiety Traits (STAI) |
11; 12 | — |
| SECONDARY Time of Prostate Biopsy |
10.6; 10.3 | — |
| SECONDARY Operator Assessment of "Tolerating Insertion of Rectal Probe" |
2; 2 | — |
| SECONDARY Operator Assessment of "Patient Maintenance of Positioning" |
2; 2 | — |
| SECONDARY Operator Assessment of "Patient Tolerance of Procedure" |
2; 2 | — |
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.
Eligibility 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:
- Inner ear, bariatric or eye surgery within the last 2 weeks,
- Current emphysematous blebs,
- Severe B-12 deficiency.
- Bleomycin chemotherapy within the past year.
- Class III or higher heart failure.
- Undergoing novel therapy for prostate cancer
Data sourced from ClinicalTrials.gov (NCT05803096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.