Nitrous Oxide Analgesia Vaso-occlusive Crisis

Sponsor

Columbia University (Other)

Overall Status

Terminated

CT.gov ID

NCT01891812

Collaborator

(none)

Enrollment

Location

Arm

50.2

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sickle Cell Disease Vaso-occlusive Crisis	Drug: Nitrous oxide 50%	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Nitrous Oxide for Analgesia in Sickle Cell Vaso-occlusive Crisis

Actual Study Start Date :

Nov 12, 2013

Actual Primary Completion Date :

Jan 19, 2018

Actual Study Completion Date :

Jan 19, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Nitrous oxide 50%

Nitrous oxide 50% administered for 15 minutes.

Drug: Nitrous oxide 50%

Outcome Measures

Primary Outcome Measures

Pain score [4 hours]
Pain score as per numeric rating scale (0 to 10; 0 = no pain, 10 = worst pain).

Secondary Outcome Measures

Duration of analgesia [4 hours]
Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.

Other Outcome Measures

Peripheral neuropathies [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 [8 weeks]
The presence of macrocytic anemia at 8 weeks time in patients who had low vitamin B12 levels at the time of enrolment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).