A Phase 2 interventional study of Nitrous oxide 50% in Sickle Cell Disease and Vaso-occlusive Crisis, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Columbia University · Phase 2, Interventional, and Treatment
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.
1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.
This study's enrollment of 5 is below the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nitrous oxide 50% administered for 20 minutes.
Drug: Nitrous oxide 50%
Pain Score
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
Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.
Time frame: Up to 4 hours
Number of Participants With Peripheral Neuropathies
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
Number of Participants With Macrocytic Anemia
The presence of macrocytic anemia at 8 weeks time in patients who had low vitamin B12 levels at the time of enrollment.
Time frame: 8 weeks
| Milestone | Nitrous Oxide |
|---|---|
| Started | 5 |
| Completed | 0 |
| Not completed | 5 |
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.
| score on a scale | Nitrous Oxide |
|---|---|
| Pain Score | 5.7 (4.6 to 6.8) |
Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.
| minutes | Nitrous Oxide |
|---|---|
| Duration of Analgesia | 39 (16 to 60) |
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
| Participants | Nitrous Oxide |
|---|---|
| Number of Participants With Peripheral Neuropathies | 0 |
The presence of macrocytic anemia at 8 weeks time in patients who had low vitamin B12 levels at the time of enrollment.
| Participants | Nitrous Oxide |
|---|---|
| Number of Participants With Macrocytic Anemia | 0 |
Collected over Up to 4 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nitrous Oxide | 0/5 (0%) | 0/5 (0%) | 2/5 (40%) |
| Event | Nitrous Oxide |
|---|---|
| NauseaGeneral disorders | 1/5 |
| VomitingGeneral disorders | 1/5 |
| Age, Customized(Participants) | Nitrous Oxide |
|---|---|
| 0 - 7 years | 0 |
| 8 - 17 years | 5 |
| 18 - 65 years | 0 |
| >65 years | 0 |
| Sex: Female, Male(Participants) | Nitrous Oxide |
|---|---|
| Female | 4 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Nitrous Oxide |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Nitrous Oxide |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Nitrous Oxide |
|---|---|
| United States | 5 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Columbia University