Nitrous Oxide Analgesia Vaso-occlusive Crisis
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|ClinicalTrials.gov Identifier: NCT01891812|
Recruitment Status : Terminated (Enrollment issues.)
First Posted : July 3, 2013
Last Update Posted : July 13, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Vaso-occlusive Crisis||Drug: Nitrous oxide 50%||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nitrous Oxide for Analgesia in Sickle Cell Vaso-occlusive Crisis|
|Actual Study Start Date :||November 12, 2013|
|Actual Primary Completion Date :||January 19, 2018|
|Actual Study Completion Date :||January 19, 2018|
Experimental: Nitrous oxide 50%
Nitrous oxide 50% administered for 15 minutes.
Drug: Nitrous oxide 50%
- Pain score [ Time Frame: 4 hours ]Pain score as per numeric rating scale (0 to 10; 0 = no pain, 10 = worst pain).
- Duration of analgesia [ Time Frame: 4 hours ]Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.
- Peripheral neuropathies [ 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
- Macrocytic anemia [ 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 enrolment.
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|Ages Eligible for Study:||8 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891812
|United States, New York|
|New York Presbyterian Morgan Stanley Children's Hospital|
|New York, New York, United States, 10032|
|Principal Investigator:||Daniel S Tsze, MD, MPH||Columbia University|
|Responsible Party:||Daniel S Tsze, MD, MPH, Associate Professor of Pediatrics in Emergency Medicine, Columbia University|
|Other Study ID Numbers:||
|First Posted:||July 3, 2013 Key Record Dates|
|Last Update Posted:||July 13, 2021|
|Last Verified:||July 2021|
Sickle cell disease
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents