Nitrous Oxide Analgesia Vaso-occlusive Crisis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-12

Study Completion Date

2018-01-19

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.

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Detailed Description

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Conditions

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Sickle Cell Disease Vaso-occlusive Crisis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nitrous oxide 50%

Nitrous oxide 50% administered for 20 minutes.

Group Type EXPERIMENTAL

Nitrous oxide 50%

Intervention Type DRUG

Interventions

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Nitrous oxide 50%

Intervention Type DRUG

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

Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No