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NCT03879538 · ClinicalTrials.gov registry record · Phase 3
Nitrous Oxide for the Treatment of Complex Regional Pain Syndrome
A Phase 3 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 44
- Enrollment target
NCT03879538: Completed Phase 3 study, sponsored by The Cleveland Clinic.
NCT03879538 is a Phase 3 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 44 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03879538, a Phase 3 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 44 participants
- Enrollment target
Study Summary
Patients will then be randomized via a web-based randomization system Redcap Allocation will be stratified based on the presence of a pre-existing spinal cord stimulator to either the nitrous oxide study group or the oxygen control group. The nitrous oxide group will receive 50% nitrous oxide mixed with 50% oxygen, and the control group will receive 50% oxygen (oxygen plus air mixture). Both groups will undergo inhalation therapy for a duration of 2 hours via an FDA-approved mask breathing circuit. Vital signs (blood pressure, respiratory rate, heart rate) will be monitored every 30 minutes. Pulse oximetry monitoring will be continuous. Patients will be monitored for side effects including nausea, vomiting, desaturation, sedation, respiratory depression, and dizziness. Patients and other involved providers will be blinded to the treatment type.
Primary Outcome
scales ranging from 0 - "no pain" to 10 - "worst pain ever" based on the PROMIS-29 v2.0 questionnaire.
Interventions
- DRUG Oxygen
- DRUG Nitrous Oxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2019-07-02 |
| Est. Completion | 2022-07-28 |
| Phase | Phase 3 |
What the finished NCT03879538 record still lists
NCT03879538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Oxygen is the first listed.
NCT03879538 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03879538 about?
NCT03879538 is a clinical study titled "Nitrous Oxide for the Treatment of Complex Regional Pain Syndrome". Patients will then be randomized via a web-based randomization system Redcap Allocation will be stratified based on the presence of a pre-existing spinal cord stimulator to either the nitrous oxide study group or the oxygen control group. The nitrous oxide group will receive 50% nitrous oxide mixed...
What is the current status of trial NCT03879538?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 44 participants. The study started on 2019-07-02. Estimated completion is 2022-07-28.
What interventions are being tested in trial NCT03879538?
The interventions under investigation include: Oxygen (DRUG), Nitrous Oxide (DRUG).
Who is sponsoring clinical trial NCT03879538?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03879538's enrollment target sits among peer trials
44 1874th of 2000 higher than 125 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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