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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 is a Phase 3 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 44 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03879538
The ClinicalTrials.gov registry entry for NCT03879538 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Oxygen is the first listed.
NCT03879538 reports 0 study locations.
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.
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