A Phase 4 interventional study of Nitrous oxide in Procedural Pain, Pain Catastrophizing and Procedural Anxiety, sponsored by Beth Israel Deaconess Medical Center. Recruiting at 1 site in United States. Open to male participants aged 21 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Beth Israel Deaconess Medical Center · Phase 4, Interventional, and Supportive care
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.
Patients scheduled for vasectomy at Beth Israel Deaconess Medical Center will be contacted and offered enrollment in the study. Vasectomy will occur according to standard-of-care and all participants will receive the typical lidocaine injections at the beginning of the procedure. Before the start of the vasectomy, a study staff member will help participants put on a plastic gas mask and demonstrate how to turn the gas up or down using the remote control. Nitrous oxide and oxygen will be given through a plastic mask. A remote control given to participants will allow them to adjust the nitrous oxide based on their comfort. The Nitrouseal® machine used in this study limits nitrous oxide to concentrations to "minimal sedation" (0-50%), which are levels where a person remains awake and is able to talk and breath normally.
Before the day of a participant's vasectomy, they will be asked questions related to demographics and medical history to determine study eligibility. Immediately before and after vasectomy, participants will be asked to describe their anxiety and pain levels. At two-weeks and three-months after vasectomy, a brief electronic survey will be sent to participants' email asking about recollection of pain and anxiety and satisfaction with the procedure.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 35 is below the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
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Exclusion Criteria:
Has any of the following medical conditions, which contraindicate use of nitrous oxide:
All patients will receive nitrous oxide at concentrations of minimal sedation (0-50%) throughout vasectomy.
Drug: Nitrous oxide
Nitrous oxide administered at concentrations of minimal sedation (0-50%). Participants will be able to adjust the level of gas throughout the vasectomy using a handheld remote control.
Also known as: Self-adjusted nitrous oxide
Procedural pain assessed by the Visual Analog Scale for Pain (VAS-P)
Level of pain experienced during vasectomy as measured by the Visual Analog Scale for Pain (VAS-P; range: 0 no pain - 10 worst pain).
Time frame: Measured immediately after completion of vasectomy
Anticipated pain assessed by the Visual Analog Scale for Pain (VAS-P)
Level of anxiety anticipated during vasectomy as measured by the Visual Analog Scale for Pain (VAS-P; range: 0 no pain - 10 worst pain).
Time frame: Measured immediately prior to vasectomy
Anticipated anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)
Level of anxiety anticipated during vasectomy as measured by the Visual Analog Scale for Anxiety (VAS-A; range: 0 no anxiety - 10 worst anxiety).
Time frame: Measured immediately prior to vasectomy
Procedural anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)
Level of anxiety experienced during vasectomy as measured by the Visual Analog Scale for Anxiety (VAS-A; range: 0 no anxiety - 10 worst anxiety).
Time frame: Measured immediately after completion of vasectomy
Recalled pain assessed by the Visual Analog Scale for Pain (VAS-P)
Level of pain recalled during vasectomy as measured by the Visual Analog Scale for Pain (VAS-P; range: 0 no pain - 10 worst pain).
Time frame: Measured two weeks and three months after vasectomy
Recalled anxiety assessed by the Visual Analog Scale for Pain (VAS-P)
Level of anxiety recalled during vasectomy as measured by the Visual Analog Scale for Anxiety (VAS-A; range: 0 no anxiety - 10 worst anxiety).
Time frame: Measured two weeks and three months after vasectomy
Satisfaction assessed by Likert scale
Satisfaction of concentration of SANO during vasectomy will be measured by the maximum concentration of SANO reached during the procedure compared to participants' response to: "How do you feel about the level of SANO you received during the vasectomy?" (less than I would like, about right, more than I would like) and "How helpful do you think SANO was in relieving your pain and anxiety?" (very helpful, unhelpful, undecided, helpful very helpful).
Time frame: Measured during and two weeks after vasectomy
Operator ease of performing vasectomy
Operating urologist will be asked to fill out a three-item "operator survey" that asks if "Patient tolerated lidocaine injection," "Patient maintained positioning," and "Patient tolerated vasectomy," "Worse than expected (-1)", "As expected (0)" or "Better than expected (+1)." The composite score will be used as a measure of operator ease.
Time frame: Measured immediately after urologist finishes vasectomy
Emergent adverse events as assessed by frequency of incidents
Emergent adverse events possibly related to SANO will be recorded by frequency on the day-of the vasectomy and by monitoring participants' online medical record up to 30 days after the vasectomy. Termination of SANO during the vasectomy due to discomfort, nausea, or vomiting will also be considered as adverse events related to SANO.
Time frame: Measured during and up to 30 days after day of vasectomy
Plan to share: No
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Studies of the drug tested here: Nitrous Oxide
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