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Phase 2 N=5 Treatment

Nitrous Oxide Analgesia Vaso-occlusive Crisis

Sickle Cell Disease · Vaso-occlusive Crisis

Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Pain Score — 5.7 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Nitrous oxide 50% (Drug)
Age
Pediatric, Adult · 8+ yrs
Sex
All
Sponsor
Columbia University
Primary completion
Jan 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Pain Score
5.7
SECONDARY
Duration of Analgesia
39

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01891812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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