Nitrous Oxide Analgesia Vaso-occlusive Crisis
Primary Purpose
Sickle Cell Disease, Vaso-occlusive Crisis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nitrous oxide 50%
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease focused on measuring Sickle cell disease, Vaso-occlusive crisis, Nitrous oxide, Emergency department
Eligibility Criteria
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
Sites / Locations
- New York Presbyterian Morgan Stanley Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nitrous oxide 50%
Arm Description
Nitrous oxide 50% administered for 15 minutes.
Outcomes
Primary Outcome Measures
Pain score
Pain score as per numeric rating scale (0 to 10; 0 = no pain, 10 = worst pain).
Secondary Outcome Measures
Duration of analgesia
Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01891812
Brief Title
Nitrous Oxide Analgesia Vaso-occlusive Crisis
Official Title
Nitrous Oxide for Analgesia in Sickle Cell Vaso-occlusive Crisis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Enrollment issues.
Study Start Date
November 12, 2013 (Actual)
Primary Completion Date
January 19, 2018 (Actual)
Study Completion Date
January 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Vaso-occlusive Crisis
Keywords
Sickle cell disease, Vaso-occlusive crisis, Nitrous oxide, Emergency department
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nitrous oxide 50%
Arm Type
Experimental
Arm Description
Nitrous oxide 50% administered for 15 minutes.
Intervention Type
Drug
Intervention Name(s)
Nitrous oxide 50%
Primary Outcome Measure Information:
Title
Pain score
Description
Pain score as per numeric rating scale (0 to 10; 0 = no pain, 10 = worst pain).
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Duration of analgesia
Description
Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.
Time Frame
4 hours
Other Pre-specified Outcome Measures:
Title
Peripheral neuropathies
Description
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
Title
Macrocytic anemia
Description
The presence of macrocytic anemia at 8 weeks time in patients who had low vitamin B12 levels at the time of enrolment.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel S Tsze, MD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Morgan Stanley Children's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
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Nitrous Oxide Analgesia Vaso-occlusive Crisis
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