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

July 29, 2015 updated by: Children's Hospitals and Clinics of Minnesota

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Children's Hospitals and Clinics of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nitrous Oxide
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease in the acute migraine pain in children and adolescents presenting to an Emergency Department
Time Frame: within 48 hours
within 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospitals and Clinics of Minnesota

Investigators

  • Principal Investigator: Andrea Hoogerland, MD, Children's Hospitals and Clinics of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 28, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (Estimate)

February 1, 2011

Study Record Updates

Last Update Posted (Estimate)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 29, 2015

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1101-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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