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OpenTrials
Completed

NCT Number: NCT01891812

Nitrous Oxide Analgesia Vaso-occlusive Crisis

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitrous oxide 50%

Drug

Primary outcomes

  1. Pain Score

    Time frame: 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 outcomes

  1. Duration of Analgesia

    Time frame: Up to 4 hours

    Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.

Other outcomes

  1. Number of Participants With Peripheral Neuropathies

    Time frame: 8 weeks

    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

  2. Number of Participants With Macrocytic Anemia

    Time frame: 8 weeks

    The presence of macrocytic anemia at 8 weeks time in patients who had low vitamin B12 levels at the time of enrollment.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Nitrous Oxide for Analgesia in Sickle Cell Vaso-occlusive Crisis

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jul 3, 2013
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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