Nitrous Oxide Analgesia Vaso-occlusive Crisis

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Columbia University

Status and phase

Terminated
Phase 2

Conditions

Vaso-occlusive Crisis
Sickle Cell Disease

Treatments

Drug: Nitrous oxide 50%

Study type

Interventional

Funder types

Other

Identifiers

NCT01891812
AAAK6900

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

8 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

Nitrous oxide 50%
Experimental group
Description:
Nitrous oxide 50% administered for 15 minutes.
Treatment:
Drug: Nitrous oxide 50%

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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