Your session is about to expire
← Back to Search
Inhalational Anesthetic
Nitrous Oxide for the Treatment of Complex Regional Pain Syndrome
Phase 3
Waitlist Available
Led By Jason Hale, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one-week and one-month follow-ups.
Awards & highlights
Pivotal Trial
Summary
This trial tests if breathing a mix of nitrous oxide and oxygen can help chronic pain patients, especially those with spinal cord stimulators, by reducing their pain and making them feel more relaxed. Nitrous oxide has been used in various settings for pain management, including emergency departments and dental treatments, showing potential for both acute and chronic pain relief.
Eligible Conditions
- Complex Regional Pain Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one-week and one-month follow-ups after treatments were ended
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one-week and one-month follow-ups after treatments were ended
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain Score
Secondary study objectives
PGIC Scale
PROMIS-29 Survey Physical Health Z-score, Mental Health Z-score
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: The nitrous oxide groupActive Control1 Intervention
Nitrous oxide group will receive 50% nitrous oxide mixed with 50% oxygen, inhalation therapy for a duration of 2 hours via an FDA-approved mask breathing circuit.
Group II: The Control GroupPlacebo Group1 Intervention
Control group will receive 50% oxygen, inhalation therapy for a duration of 2 hours via an FDA-approved mask breathing circuit.
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,056 Previous Clinical Trials
1,371,573 Total Patients Enrolled
Jason Hale, MDPrincipal InvestigatorAnesthesiologist