Sickle Cell Disease, Vaso-occlusive Crisis
Conditions
Keywords
Sickle cell disease, Vaso-occlusive crisis, Nitrous oxide, Emergency department
Brief 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. 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.
Interventions
Sponsors
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Analgesia | Up to 4 hours | Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel S Tsze, MD, MPH
Columbia University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Nitrous Oxide |
|---|---|
| Age, Customized 0 - 7 years | 0 Participants |
| Age, Customized 18 - 65 years | 0 Participants |
| Age, Customized >65 years | 0 Participants |
| Age, Customized 8 - 17 years | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 2 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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.
Time frame: Up to 4 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nitrous Oxide | Pain Score | 5.7 score on a scale |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nitrous Oxide | Duration of Analgesia | 39 minutes |
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.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nitrous Oxide | Number of Participants With Macrocytic Anemia | 0 Participants |
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
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nitrous Oxide | Number of Participants With Peripheral Neuropathies | 0 Participants |