Sickle Cell DiseasePhase 2NCT01891812
Nitrous Oxide Analgesia Vaso-occlusive Crisis
A Phase 2 study testing Nitrous oxide 50% in people with Sickle Cell Disease and Vaso-occlusive Crisis, run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Sickle Cell Disease, Vaso-occlusive Crisis
- What is being tested?
- Nitrous oxide 50%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2013to 19 Jan 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Morgan Stanley Children's Hospital
New York, New York, 10032
About this study
Official title: Nitrous Oxide for Analgesia in Sickle Cell Vaso-occlusive Crisis
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.
- Conditions
- Sickle Cell Disease, Vaso-occlusive Crisis
- Being tested
- Nitrous oxide 50%
- Keywords
- Sickle cell disease, Vaso-occlusive crisis, Nitrous oxide, Emergency department
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous oxide 50%Drug
| Study group | Role | What they receive |
|---|---|---|
| Nitrous oxide 50% | Experimental | Nitrous oxide 50% administered for 20 minutes. Receives: Drug: Nitrous oxide 50% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 hours
Secondary outcomes (1)
Duration of Analgesia
Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.
Measured: Up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study start12 Nov 2013
- Primary completion19 Jan 2018
- Study completion19 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel S Tsze, MD, MPH, Columbia University
- Investigators
- Daniel S Tsze, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891812
- Sponsor's protocol ID
- AAAK6900
- Status last verified
- Jan 2026
- First submitted
- 29 Jun 2013
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Tsze DS, Licursi M, Ender KL, Kennedy RM, Dayan PS. Nitrous Oxide for Treating Vaso-Occlusive Crisis Pain in Children With Sickle Cell Disease: A Pilot Study. Acad Emerg Med. 2026 Mar;33(3):e70203. doi: 10.1111/acem.70203. Epub 2025 Nov 28. No abstract available.
PubMed 41315052
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrous Oxide for Analgesia in Sickle Cell Vaso-occlusive Crisis
- ClinicalTrials.gov ID
- NCT01891812
- Acronym / sponsor ID
- AAAK6900
- Conditions
- Sickle Cell Disease, Vaso-occlusive Crisis
- Keywords
- Sickle cell disease, Vaso-occlusive crisis, Nitrous oxide, Emergency department
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 12 Nov 2013 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Posted 16 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nitrous oxide 50% | Experimental | Drug: Nitrous oxide 50%Nitrous oxide 50% administered for 20 minutes. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous oxide 50% | Drug | Nitrous oxide 50% |
Primary outcome
Pain Score
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.
1 secondary outcome
Duration of Analgesia
Time frame: Up to 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41315052Tsze DS, Licursi M, Ender KL, Kennedy RM, Dayan PS. Nitrous Oxide for Treating Vaso-Occlusive Crisis Pain in Children With Sickle Cell Disease: A Pilot Study. Acad Emerg Med. 2026 Mar;33(3):e70203. doi: 10.1111/acem.70203. Epub 2025 Nov 28. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel S Tsze, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitrous oxide 50% in people with Sickle Cell Disease and Vaso-occlusive Crisis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: Up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01891812, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.