Nitrous Oxide Analgesia Vaso-occlusive Crisis

Phase 2

Terminated

• Conditions: Sickle Cell Disease; Vaso-occlusive Crisis
• Interventions: Drug: Nitrous oxide 50%

• Registration Number: NCT01891812
• Lead Sponsor: Columbia University

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 available

Study Timeline

• Study First Submitted: 2013-06-29
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-03
• Study Start: 2013-11-12
• Primary Completion: 2018-01-19
• Study Completion: 2018-01-19
• Status Verified: 2024-06
• Results First Submitted: 2024-06-21
• Results First Submitted QC: 2024-06-21
• Last Update Submitted: 2024-06-21
• Results First Posted: 2024-07-16
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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).

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nitrous oxide 50%	Nitrous oxide 50%	Nitrous oxide 50% administered for 20 minutes.

Primary Outcome Measures

Name	Time	Method
Pain Score	Up to 4 hours	Patient-reported pain score immediately after administration of nitrous oxide. The full range of the pain score is 0 to 10; 0 = no pain, 10 = worst pain.

Secondary Outcome Measures

Name	Time	Method
Duration of Analgesia	Up to 4 hours	Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.

Trial Locations

Locations (1)

New York Presbyterian Morgan Stanley Children's Hospital; 🇺🇸 New York, New York, United States