Trial Outcomes & Findings for Nitrous Oxide Analgesia Vaso-occlusive Crisis (NCT NCT01891812)
NCT ID: NCT01891812
Last Updated: 2026-01-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Up to 4 hours
Results posted on
2026-01-28
Participant Flow
Participant milestones
| Measure |
Nitrous Oxide
Patients with Sickle cell disease and experiencing vaso-occlusive crises (VOC) with a pain score of greater than or equal to 7/10.
Patients will receive the standard care of IV fluids, NSAIDs, and IV morphine or hydromorphone. The pain score will be reassessed 15 minutes after the initial pain scoring, and if the pain score is still greater than or equal to 7/10, nitrous oxide (N2O) will be administered at a concentration of 50% for 20 minutes.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nitrous Oxide Analgesia Vaso-occlusive Crisis
Baseline characteristics by cohort
| Measure |
Nitrous Oxide
n=5 Participants
Patients with Sickle cell disease and experiencing vaso-occlusive crises (VOC) with a pain score of greater than or equal to 7/10.
Patients will receive the standard care of IV fluids, NSAIDs, and IV morphine or hydromorphone. The pain score will be reassessed 15 minutes after the initial pain scoring, and if the pain score is still greater than or equal to 7/10, nitrous oxide (N2O) will be administered at a concentration of 50% for 20 minutes.
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|---|---|
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Age, Customized
0 - 7 years
|
0 Participants
n=158 Participants
|
|
Age, Customized
8 - 17 years
|
5 Participants
n=158 Participants
|
|
Age, Customized
18 - 65 years
|
0 Participants
n=158 Participants
|
|
Age, Customized
>65 years
|
0 Participants
n=158 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=158 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=158 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=158 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=158 Participants
|
PRIMARY outcome
Timeframe: Up to 4 hoursPatient-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.
Outcome measures
| Measure |
Nitrous Oxide
n=5 Participants
Patients with Sickle cell disease and experiencing vaso-occlusive crises (VOC) with a pain score of greater than or equal to 7/10.
Patients will receive the standard care of IV fluids, NSAIDs, and IV morphine or hydromorphone. The pain score will be reassessed 15 minutes after the initial pain scoring, and if the pain score is still greater than or equal to 7/10, nitrous oxide (N2O) will be administered at a concentration of 50% for 20 minutes.
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|---|---|
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Pain Score
|
5.7 score on a scale
Interval 4.6 to 6.8
|
SECONDARY outcome
Timeframe: Up to 4 hoursDuration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.
Outcome measures
| Measure |
Nitrous Oxide
n=5 Participants
Patients with Sickle cell disease and experiencing vaso-occlusive crises (VOC) with a pain score of greater than or equal to 7/10.
Patients will receive the standard care of IV fluids, NSAIDs, and IV morphine or hydromorphone. The pain score will be reassessed 15 minutes after the initial pain scoring, and if the pain score is still greater than or equal to 7/10, nitrous oxide (N2O) will be administered at a concentration of 50% for 20 minutes.
|
|---|---|
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Duration of Analgesia
|
39 minutes
Interval 16.0 to 60.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksComplaints 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
Outcome measures
| Measure |
Nitrous Oxide
n=5 Participants
Patients with Sickle cell disease and experiencing vaso-occlusive crises (VOC) with a pain score of greater than or equal to 7/10.
Patients will receive the standard care of IV fluids, NSAIDs, and IV morphine or hydromorphone. The pain score will be reassessed 15 minutes after the initial pain scoring, and if the pain score is still greater than or equal to 7/10, nitrous oxide (N2O) will be administered at a concentration of 50% for 20 minutes.
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|---|---|
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Number of Participants With Peripheral Neuropathies
|
0 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksThe presence of macrocytic anemia at 8 weeks time in patients who had low vitamin B12 levels at the time of enrollment.
Outcome measures
| Measure |
Nitrous Oxide
n=5 Participants
Patients with Sickle cell disease and experiencing vaso-occlusive crises (VOC) with a pain score of greater than or equal to 7/10.
Patients will receive the standard care of IV fluids, NSAIDs, and IV morphine or hydromorphone. The pain score will be reassessed 15 minutes after the initial pain scoring, and if the pain score is still greater than or equal to 7/10, nitrous oxide (N2O) will be administered at a concentration of 50% for 20 minutes.
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|---|---|
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Number of Participants With Macrocytic Anemia
|
0 Participants
|
Adverse Events
Nitrous Oxide
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nitrous Oxide
n=5 participants at risk
Patients with Sickle cell disease and experiencing vaso-occlusive crises (VOC) with a pain score of greater than or equal to 7/10.
Patients will receive the standard care of IV fluids, NSAIDs, and IV morphine or hydromorphone. The pain score will be reassessed 15 minutes after the initial pain scoring, and if the pain score is still greater than or equal to 7/10, nitrous oxide (N2O) will be administered at a concentration of 50% for 20 minutes.
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|---|---|
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General disorders
Nausea
|
20.0%
1/5 • Up to 4 hours
|
|
General disorders
Vomiting
|
20.0%
1/5 • Up to 4 hours
|
Additional Information
Dr. Daniel Tsze, Professor of Pediatrics
Columbia University Irving Medical Center
Phone: 212 305 9825
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place