Nitrous Oxide Analgesia Vaso-occlusive Crisis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01891812|
Recruitment Status : Terminated (Enrollment issues.)
First Posted : July 3, 2013
Last Update Posted : July 13, 2021
|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.
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|