Nitrous Oxide for Analgesia in Sickle Cell Vaso-occlusive Crisis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Pain Score
Study Overview
Brief Summary
Patients who have sickle cell VOC are usually treated with opioids, such as morphine. However, this current way of treating them has not improved the health, medical outcomes, or rates of hospitalizations. In addition, since VOC can happen very frequently over a long period of time, giving opioids over and over again can cause both short-term and long-term problems. Nitrous oxide (N2O) is a way of treating pain that may provide a better alternative to repeatedly giving opioids over long periods of time. N2O has been shown to provide up to 3 hours of pain relief in inpatient patients with VOC whose pain did not improve with morphine infusions, and is used extensively in France, where almost half of 85 pediatric emergency departments use nitrous oxide to treat children with VOC whose pain did not get better with standard treatment with morphine. However, pain relief which N2O provides in the acute setting has not been well described. Therefore, the purpose of our study is to describe how well N2O can relieve the pain in patients with SCD who present to the emergency department and are experiencing a VOC.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with sickle cell disease
- •Ages 8 to 18, inclusive
- •Present to the pediatric emergency department with VOC and whose pain scores remain greater than or equal to 7/10 on the NRS after initial standard treatment (i.e. IV fluids, morphine and NSAIDs).
Exclusion Criteria
- •life-threatening illness as determined by attending clinician
- •developmental delay
- •altered level of consciousness
- •any contraindications to receiving N2O
- •foster children and wards of the state
Arms & Interventions
Nitrous oxide 50%
Nitrous oxide 50% administered for 20 minutes.
Intervention: Nitrous oxide 50% (Drug)
Outcomes
Primary Outcomes
Pain Score
Time Frame: Up to 4 hours
Patient-reported pain score immediately after administration of nitrous oxide. The full range of the pain score is 0 to 10; 0 = no pain, 10 = worst pain.
Secondary Outcomes
- Duration of Analgesia(Up to 4 hours)
Investigators
Daniel S Tsze, MD, MPH
Associate Professor of Pediatrics in Emergency Medicine
Columbia University
