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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01287052
First Posted: February 1, 2011
Last Update Posted: July 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota
  Purpose

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.


Condition Intervention
Migraine Pain Drug: Nitrous Oxide

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nitrous Oxide for Acute Pediatric Migraine Pain Management in the Emergency Room

Resource links provided by NLM:


Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • Decrease in the acute migraine pain in children and adolescents presenting to an Emergency Department [ Time Frame: within 48 hours ]

Estimated Enrollment: 30
Study Start Date: June 2011
Study Completion Date: January 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287052


Locations
United States, Minnesota
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Investigators
Principal Investigator: Andrea Hoogerland, MD Children's Hospitals and Clinics of Minnesota
  More Information

Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT01287052     History of Changes
Other Study ID Numbers: 1101-006
First Submitted: January 28, 2011
First Posted: February 1, 2011
Last Update Posted: July 30, 2015
Last Verified: April 2014

Keywords provided by Children's Hospitals and Clinics of Minnesota:
Migraine
Pediatric
Adolescent
Nitrous Oxide

Additional relevant MeSH terms:
Emergencies
Migraine Disorders
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents