Nitrous Oxide Analgesia Vaso-occlusive Crisis

Sickle Cell Disease Clinical Trial

Official title:

Nitrous Oxide for Analgesia in Sickle Cell Vaso-occlusive Crisis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01891812
• Other study ID #: AAAK6900
• Status: Terminated
• Phase: Phase 2
• Start date: November 12, 2013
• Est. completion date: January 19, 2018

Study information

• Verified date: July 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 19, 2018
• Est. primary completion date: January 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease
• Vaso-occlusive Crisis

Intervention

Drug:
• Nitrous oxide 50%

Locations

Country	Name	City	State
United States	New York Presbyterian Morgan Stanley Children's Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Peripheral neuropathies	Complaints or physical ?ndings suggestive of peripheral neuropathies (which may present as numbness, tingling, pain, or loss of feeling in ?ngers or toes; or weakness or dif?culty moving the arms or legs) at the 8 week follow-up	8 weeks
Other	Macrocytic anemia	The presence of macrocytic anemia at 8 weeks time in patients who had low vitamin B12 levels at the time of enrolment.	8 weeks
Primary	Pain score	Pain score as per numeric rating scale (0 to 10; 0 = no pain, 10 = worst pain).	4 hours
Secondary	Duration of analgesia	Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.	4 hours