Nitrous Oxide Analgesia Vaso-occlusive Crisis

Nitrous Oxide for Analgesia in Sickle Cell 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.

Study Overview

• Status: Terminated
• Conditions: Sickle Cell Disease; Vaso-occlusive Crisis
• Intervention / Treatment: Drug: Nitrous oxide 50%

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian Morgan Stanley Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nitrous oxide 50%; Nitrous oxide 50% administered for 15 minutes.	Drug: Nitrous oxide 50%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Pain score as per numeric rating scale (0 to 10; 0 = no pain, 10 = worst pain).	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of analgesia	Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.	4 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral neuropathies	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	8 weeks
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

Collaborators and Investigators

• Sponsor: Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2013
• Primary Completion (Actual): January 19, 2018
• Study Completion (Actual): January 19, 2018

Study Registration Dates

• First Submitted: June 29, 2013
• First Submitted That Met QC Criteria: July 2, 2013
• First Posted (Estimate): July 3, 2013

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Emergency department; Sickle cell disease; Nitrous oxide; Vaso-occlusive crisis
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: AAAK6900