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

Primary Purpose

Migraine, Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nitrous Oxide
Sponsored by
Children's Hospitals and Clinics of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Pediatric, Adolescent, Nitrous Oxide

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospitals and Clinics of Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nitrous Oxide

Arm Description

Outcomes

Primary Outcome Measures

Decrease in the acute migraine pain in children and adolescents presenting to an Emergency Department

Secondary Outcome Measures

Full Information

First Posted
January 28, 2011
Last Updated
July 29, 2015
Sponsor
Children's Hospitals and Clinics of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01287052
Brief Title
Nitrous Oxide for Acute Migraine Pain in the Emergency Room (ED)
Official Title
Nitrous Oxide for Acute Pediatric Migraine Pain Management in the Emergency Room
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospitals and Clinics of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Pain
Keywords
Migraine, Pediatric, Adolescent, Nitrous Oxide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nitrous Oxide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nitrous Oxide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decrease in the acute migraine pain in children and adolescents presenting to an Emergency Department
Time Frame
within 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Hoogerland, MD
Organizational Affiliation
Children's Hospitals and Clinics of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospitals and Clinics of Minnesota
City
Minneapolis
State/Province
Minnesota
Country
United States

12. IPD Sharing Statement

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

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