Using self-adjusted nitrous oxide to manage pain and anxiety during vasectomy
Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
This study is testing if letting patients control their nitrous oxide levels during a vasectomy can help reduce their pain and anxiety.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 21 Years to 85 Years |
| Sex | Male |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05895383 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of using self-adjusted nitrous oxide to reduce pain and anxiety during vasectomy procedures. Patients scheduled for vasectomy at Beth Israel Deaconess Medical Center will be enrolled and provided with a remote-controlled gas mask to adjust their nitrous oxide levels during the procedure. Participants will complete surveys before, immediately after, and at two weeks and three months post-procedure to assess their pain, anxiety, and overall satisfaction. The goal is to determine if allowing patients to control their nitrous oxide intake improves their experience of care.
Who should consider this trial
Good fit: Ideal candidates are men aged 21 to 85 who are scheduled for a vasectomy and can safely receive inhaled nitrous oxide.
Not a fit: Patients with certain medical conditions that contraindicate the use of nitrous oxide or those unable to complete surveys may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient comfort and satisfaction during vasectomy procedures.
How similar studies have performed: Previous studies have shown positive outcomes with nitrous oxide for procedural pain management, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Scheduled for vasectomy 2. Aged 21 to 85 years 3. Suitable for receipt of inhaled nitrous oxide/oxygen 4. Access to an email and computer Exclusion Criteria: 1. Perioral facial hair impeding good mask seal 2. Cognitive impairment that impedes ability to complete survey questions 3. Intent to use benzodiazepines or opioids "as needed" for purposes of vasectomy 4. Has any of the following medical conditions, which contraindicate use of nitrous oxide: 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. Heart attack within the past year, 6. Stroke within the past year, 7. Class III or higher heart failure.
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Heidi Rayala, MD, PhD — Beth Israel Deaconess Medical Center
- Study coordinator: Heidi Rayala, MD, PhD
- Email: hrayala@bidmc.harvard.edu
- Phone: 617-667-3739
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.