Nitrous Oxide Analgesia Vaso-occlusive Crisis

Study Overview
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Brief Summary
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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.

Official Title
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Nitrous Oxide for Analgesia in Sickle Cell Vaso-occlusive Crisis

Conditions
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Sickle Cell Disease, Vaso-occlusive Crisis

Intervention / Treatment
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* Drug: Nitrous oxide 50%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitrous oxide 50%<br>Nitrous oxide 50% administered for 15 minutes. | Drug: Nitrous oxide 50%<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain score as per numeric rating scale (0 to 10; 0 = no pain, 10 = worst pain). | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of analgesia | Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia. | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nitrous oxide, Sickle cell disease, Vaso-occlusive crisis, Emergency department