Nitrous Oxide for Acute Migraine Pain in the Emergency Room (ED)

Pain Clinical Trial

Official title:

Nitrous Oxide for Acute Pediatric Migraine Pain Management in the Emergency Room

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287052
• Other study ID #: 1101-006
• Status: Completed
• Phase: N/A
• First received: January 28, 2011
• Last updated: July 29, 2015
• Start date: June 2011
• Est. completion date: January 2015

Study information

• Verified date: April 2014
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

BACKGROUND Migraine headaches account for 8-18% of all headaches seen in pediatric emergency rooms. Standard treatment includes IV pain medications, anti-emetics, and IV fluids. Nitrous oxide has analgesic properties similar to those of opioids and is easy to administer. It has been shown in two small studies to be effective in treating migraine headaches.

RESEARCH QUESTION Does nitrous oxide act as a safe, less invasive, and effective treatment of acute migraine headaches in children and adolescents presenting to an Emergency Department?

DESIGN This is a prospective non-randomized self-controlled study. Repeated measures will be taken to examine change in pain scores before and after nitrous oxide treatment.

METHODS Each participant will be given nitrous oxide until he/she reports a pain score of zero or up to fifteen minutes. Study subjects will be asked to rate their pain on a scale of 0-10 before the treatment and after the treatment at multiple time-points.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• During the study enrollment period, eligible subjects will be English-speaking children and adolescents

• Between the ages of 8 - 18 years (inclusive)

• With history of migraine present for at least one year

• With previous migraine headaches conforming to ICHD-II diagnostic criteria

• Able to give assent according to institutional guidelines, and

• Have parental consent to participate.

Exclusion Criteria:

• Any patients will be excluded if he/she

• Has had any neurosurgical interventions

• Has underlying seizure disorders

• Presents with a headache of a different quality than their other migraines

• Has contraindications to nitrous oxide

• Unable to complete the pain assessment

• Does not have a dependable contact number for the follow-up call

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Pain

Intervention

Drug:
• Nitrous Oxide
Once consent is obtained, the research assistant will notify the charge RN and MD of the patient's study participation. The patient will then be placed in a treatment room and nitrous oxide will be administered per the existing protocol. Each participant will be given nitrous oxide until he/she reports a pain score of zero or up to fifteen minutes. Study subjects will be asked to rate their pain on a scale of 0-10 before the treatment and after the treatment, the time duration of administering nitrous oxide will be recorded. In addition, the pain scores at 30, 60, 90, and 120 minutes post baseline measurement will be collected in order to evaluate the sustained effect of nitrous oxide in treating acute migraine pain. Someone from the study will also make a follow-up phone call 24 - 48 hours to see if pain relief persisted.

Locations

Country	Name	City	State
United States	Children's Hospitals and Clinics of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in the acute migraine pain in children and adolescents presenting to an Emergency Department		within 48 hours	No