New York Presbyterian Morgan Stanley Children's Hospital
New York, 10032, United States
NCT Number: NCT01891812
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.
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Notify Me8 year–18 year
All sexes
Interventional
Phase 2
New York, 10032, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to 4 hours
Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.
Time frame: 8 weeks
Complaints or physical findings suggestive of peripheral neuropathies (which may present as numbness, tingling, pain, or loss of feeling in fingers or toes; or weakness or difficulty moving the arms or legs) at the 8 week follow-up
Time frame: 8 weeks
The presence of macrocytic anemia at 8 weeks time in patients who had low vitamin B12 levels at the time of enrollment.
Columbia University
Other
Nitrous Oxide for Analgesia in Sickle Cell Vaso-occlusive Crisis
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