Nitrous Oxide Analgesia Vaso-occlusive Crisis

NCT01891812 | Completed Phase 2 Results DMC

• 1 other identifier: AAAK6900
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Vaso-occlusive Crisis

Keywords

Sickle cell disease; Vaso-occlusive crisis; Nitrous oxide; Emergency department

Outcome Measures

Primary Outcomes (1)

• Pain Score

  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.

  Up to 4 hours

Secondary Outcomes (1)

• Duration of Analgesia

  Up to 4 hours

Other Outcomes (2)

• Number of Participants With Peripheral Neuropathies

  8 weeks

• Number of Participants With Macrocytic Anemia

  8 weeks

Study Arms (1)

Nitrous oxide 50%

EXPERIMENTAL

Nitrous oxide 50% administered for 20 minutes.

Drug: Nitrous oxide 50%

Interventions

Nitrous oxide 50% DRUG

Nitrous oxide 50%

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

New York Presbyterian Morgan Stanley Children's Hospital

New York, New York, 10032, United States

Location

Related Publications (1)

• Tsze DS, Licursi M, Ender KL, Kennedy RM, Dayan PS. Nitrous Oxide for Treating Vaso-Occlusive Crisis Pain in Children With Sickle Cell Disease: A Pilot Study. Acad Emerg Med. 2026 Mar;33(3):e70203. doi: 10.1111/acem.70203. Epub 2025 Nov 28. No abstract available.

  PMID: 41315052 RESULT

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises; Emergencies

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Daniel Tsze, Professor of Pediatrics
• Organization: Columbia University Irving Medical Center

dst2141@cumc.columbia.edu

212 305 9825

Study Officials

• Daniel S Tsze, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics in Emergency Medicine

Study Record Dates

• First Submitted: June 29, 2013
• First Posted: July 3, 2013
• Study Start: November 12, 2013
• Primary Completion: January 19, 2018
• Study Completion: January 19, 2018
• Last Updated: January 28, 2026
• Results First Posted: July 16, 2024

Record last verified: 2026-01

Locations

US (1)