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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
Sponsor:
Information provided by (Responsible Party):
Daniel S Tsze, MD, MPH, Columbia University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Vaso-occlusive Crisis Drug: Nitrous oxide 50% Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nitrous Oxide for Analgesia in Sickle Cell Vaso-occlusive Crisis
Actual Study Start Date : November 12, 2013
Actual Primary Completion Date : January 19, 2018
Actual Study Completion Date : January 19, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nitrous oxide 50%
Nitrous oxide 50% administered for 15 minutes.
 Drug: Nitrous oxide 50%


Outcome Measures
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Primary Outcome Measures :
  1. Pain score [ Time Frame: 4 hours ]
    Pain score as per numeric rating scale (0 to 10; 0 = no pain, 10 = worst pain).


Secondary Outcome Measures :
  1. Duration of analgesia [ Time Frame: 4 hours ]
    Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.


Other Outcome Measures:
  1. 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. 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.


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891812


Locations
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United States, New York
New York Presbyterian Morgan Stanley Children's Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Daniel S Tsze, MD, MPH Columbia University
More Information
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Responsible Party: Daniel S Tsze, MD, MPH, Associate Professor of Pediatrics in Emergency Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01891812    
Other Study ID Numbers: AAAK6900
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Keywords provided by Daniel S Tsze, MD, MPH, Columbia University:
Sickle cell disease
Vaso-occlusive crisis
Nitrous oxide
Emergency department
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Nitrous Oxide
Anesthetics, Inhalation
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents