We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Nitrous Oxide Analgesia Vaso-occlusive Crisis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01891812
Recruitment Status : Terminated (Enrollment issues.)
First Posted : July 3, 2013
Last Update Posted : July 13, 2021
Information provided by (Responsible Party):
Daniel S Tsze, MD, MPH, Columbia University

Tracking Information
First Submitted Date  ICMJE June 29, 2013
First Posted Date  ICMJE July 3, 2013
Last Update Posted Date July 13, 2021
Actual Study Start Date  ICMJE November 12, 2013
Actual Primary Completion Date January 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
Pain score [ Time Frame: 4 hours ]
Pain score as per numeric rating scale (0 to 10; 0 = no pain, 10 = worst pain).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
Duration of analgesia [ Time Frame: 4 hours ]
Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 2, 2013)
  • 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
  • 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 enrolment.
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Nitrous Oxide Analgesia Vaso-occlusive Crisis
Official Title  ICMJE Nitrous Oxide for Analgesia in Sickle Cell Vaso-occlusive Crisis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sickle Cell Disease
  • Vaso-occlusive Crisis
Intervention  ICMJE Drug: Nitrous oxide 50%
Study Arms  ICMJE Experimental: Nitrous oxide 50%
Nitrous oxide 50% administered for 15 minutes.
Intervention: Drug: Nitrous oxide 50%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 28, 2020)
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2013)
Actual Study Completion Date  ICMJE January 19, 2018
Actual Primary Completion Date January 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01891812
Other Study ID Numbers  ICMJE AAAK6900
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Daniel S Tsze, MD, MPH, Columbia University
Original Responsible Party Daniel Sing-Kwong Tsze, Columbia University, Assistant Professor of Pediatrics
Current Study Sponsor  ICMJE Columbia University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel S Tsze, MD, MPH Columbia University
PRS Account Columbia University
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP