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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrous oxide 50% | Experimental | Nitrous oxide 50% administered for 20 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrous oxide 50% | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Analgesia | Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia. | Up to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 weeks |
| Number of Participants With Macrocytic Anemia |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel S Tsze, MD, MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Morgan Stanley Children's Hospital | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41315052 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Up to 4 hours |
|
Up to 4 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Tsze, Professor of Pediatrics | Columbia University Irving Medical Center | 212 305 9825 | dst2141@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2018 | Jun 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D000098644 | Vaso-Occlusive Crises |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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The presence of macrocytic anemia at 8 weeks time in patients who had low vitamin B12 levels at the time of enrollment. |
| 8 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Duration of Analgesia | Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia. | Posted | Mean | 95% Confidence Interval | minutes | Up to 4 hours |
|
|
|
| Other Pre-specified | 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 | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 2 |
| 5 |
| Vomiting | General disorders | Non-systematic Assessment |
|
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |