Nitrous Oxide Analgesia Vaso-occlusive Crisis

• ClinicalTrials.gov Identifier: NCT01891812
• Recruitment Status: Terminated
• First Posted: July 3, 2013
• Last Update Posted: July 13, 2021
• Sponsor: Columbia University
• Information provided by (Responsible Party): Daniel S Tsze, MD, MPH, Columbia University

Tracking Information

• First Submitted Date: June 29, 2013
• First Posted Date: July 3, 2013
• Last Update Posted Date: July 13, 2021
• Actual Study Start Date: November 12, 2013
• Actual Primary Completion Date: January 19, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: Nitrous Oxide Analgesia Vaso-occlusive Crisis
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Sickle Cell Disease
• Vaso-occlusive Crisis

• Intervention: Drug: Nitrous oxide 50%

Study Arms

Experimental: Nitrous oxide 50%

Nitrous oxide 50% administered for 15 minutes.

Intervention: Drug: Nitrous oxide 50%

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 28, 2020): 5
• Original Estimated Enrollment (submitted: July 2, 2013): 12
• Actual Study Completion Date: January 19, 2018
• Actual Primary Completion Date: January 19, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 8 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01891812
• Other Study ID Numbers: AAAK6900
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: Columbia University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Daniel S Tsze, MD, MPH; Columbia University

• PRS Account: Columbia University
• Verification Date: July 2021