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New treatment option for Procedural Pain
Official title Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
ClinicalTrials.gov ID: NCT05895383
What this study is testing
What is Nitrous oxide?
Nitrous oxide is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for procedural pain.
Also referred to as Self-adjusted nitrous oxide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is being done to see if nitrous oxide during vasectomy decreases pain and anxiety, and also assess whether patients have better satisfaction when they control their own level of nitrous oxide during the procedure. If we find that patients experience less pain or anxiety with nitrous oxide, it could be suggested that self-adjusted nitrous oxide (SANO) may be a useful tool for improving experience of care during vasectomy.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 85, men only. Healthy volunteers may be eligible.
You may be able to join if
- Scheduled for vasectomy
- Aged 21 to 85 years
- Suitable for receipt of inhaled nitrous oxide/oxygen
- Access to an email and computer
You likely can't join if
- Perioral facial hair impeding good mask seal
- Cognitive impairment that impedes ability to complete survey questions
- Intent to use benzodiazepines or opioids "as needed" for purposes of vasectomy
- Has any of the following medical conditions, which contraindicate use of nitrous oxide:
- Inner ear, bariatric or eye surgery within the last 2 weeks,
- Current emphysematous blebs,
See the full eligibility criteria
- Scheduled for vasectomy
- Aged 21 to 85 years
- Suitable for receipt of inhaled nitrous oxide/oxygen
- Access to an email and computer
- Perioral facial hair impeding good mask seal
- Cognitive impairment that impedes ability to complete survey questions
- Intent to use benzodiazepines or opioids "as needed" for purposes of vasectomy
- Has any of the following medical conditions, which contraindicate use of nitrous oxide:
- Inner ear, bariatric or eye surgery within the last 2 weeks,
- Current emphysematous blebs,
- Severe B-12 deficiency,
- Bleomycin chemotherapy within the past year,
- Heart attack within the past year,
- Stroke within the past year,
- Class III or higher heart failure.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 21 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.