Self-adjusted nitrous oxide versus placebo during in-office vasectomy
Official title: A Single-Blind Randomized Placebo Controlled Trial of Self-Adjusted Nitrous Oxide During Office Vasectomy
Run by Brigham and Women's Hospital · NCT07245628 · Data updated 2026-11-12
This will see if self-administered low-dose nitrous oxide (20–45%) helps reduce anxiety, catastrophizing, and pain for adults having an in-office vasectomy.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | Men only |
| Enrollment | 50 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | October 20, 2025 |
| Main results expected | May 1, 2028 |
| Study ends | May 1, 2030 |
| Registry record updated | November 24, 2025 |
| Trial ID | NCT07245628 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult men aged 18–85 seeking an office vasectomy who can consent, complete questionnaires, and do not have contraindications to nitrous oxide or recent daily benzodiazepine/opioid use.
✕Probably not a fit
Men with surgical anatomy unsuitable for office vasectomy, those requiring monitored anesthesia care, or those with contraindications to nitrous oxide (recent ear/bariatric/eye surgery, emphysematous blebs, severe B12 deficiency, recent bleomycin, or class III+ heart failure) are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase interventional trial compares self-administered low-dose nitrous oxide (20–45%) with placebo oxygen during office vasectomy procedures. Participants self-administer gas during the procedure and complete questionnaires before, during, and after the operation about anxiety, catastrophizing, and pain. Secondary outcomes include procedure duration, adverse event rates, and urologists' ratings of ease and patient tolerance. The single-site study is conducted at Brigham and Women's Hospital and enrolls adults aged 18–85 who desire vasectomy and have no contraindications to nitrous oxide.
Why it matters
Potential benefit: If successful, this approach could make vasectomies less anxiety-provoking and painful, improving patient comfort and procedure tolerance.
How similar studies have gone: Nitrous oxide has a long history of safe anxiety and pain relief in dental and obstetric settings, but its use specifically for office vasectomy is relatively novel and not well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 - 85 at the time of screening * Desiring vasectomy for family planning purposes * Able to understand and complete patient questionnaires * Willing and able to provide written consent to participate in the study Exclusion Criteria: * Patients with unilateral absence of the vas deferens * Patients who are deemed by study surgeons to have anatomy no amendable for office procedure * Patients who decline office vasectomy and request monitored anesthesia care * Patients taking benzodiazepine or narcotic medication daily or within 24 hours of the procedure * Patients with contraindications to nitrous oxide including: * Inner ear, bariatric, or eye surgery within the past 2 weeks * Current emphysematous blebs * Severe B-12 deficiency * History of bleomycin chemotherapy within the last year * Class III or higher heart failure
Where it's running
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Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Post-Vasectomy Pain Management Aftercare
This study tests four pain-control regimens after vasectomy to see which helps men feel better and how much pain relief they get.
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Vasectomy: Right for Me? — a web-based decision aid
A web-based decision aid helps men think clearly about vasectomy and other birth control options to see if it fits their goals.
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Guided-meditation virtual reality during vasectomy to reduce pain and anxiety
This project will test whether wearing a TRIPP guided-meditation VR headset during vasectomy helps adult men have less pain, less anxiety, and greater satisfaction than standard care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.