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NCT05803096 · ClinicalTrials.gov registry record · Phase 4
Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain
A Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 143
- Enrollment target
NCT05803096: Completed Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
NCT05803096 is a Phase 4 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 143 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05803096, a Phase 4 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 143 participants
- Enrollment target
Study 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.
Primary Outcome
Pain experienced immediately following prostate biopsy as measured by a Visual Analog Scale for Pain (VAS-P) (range: 0 \[no pain\] - 10 \[worst pain\])
Interventions
- OTHER Oxygen
- DRUG Self-Administered Nitrous Oxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2021-12-12 |
| Est. Completion | 2022-09-09 |
| Phase | Phase 4 |
What the finished NCT05803096 record still lists
NCT05803096 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Oxygen is the first listed.
NCT05803096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05803096 about?
NCT05803096 is a clinical study titled "Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain". 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 ...
What is the current status of trial NCT05803096?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 143 participants. The study started on 2021-12-12. Estimated completion is 2022-09-09.
What interventions are being tested in trial NCT05803096?
The interventions under investigation include: Oxygen (OTHER), Self-Administered Nitrous Oxide (DRUG).
Who is sponsoring clinical trial NCT05803096?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05803096's enrollment target sits among peer trials
143 580th of 2000 higher than 1,421 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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