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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Children's Hospitals and Clinics of Minnesota
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT01287052
First received: January 28, 2011
Last updated: April 21, 2014
Last verified: April 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: August 2014
Estimated 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

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287052

Contacts
Contact: Andrea Hoogerland, MD 612-813-3300 andrea.hoogerland@childrensmn.org

Locations
United States, Minnesota
Children's Hospitals and Clinics of Minnesota Recruiting
Minneapolis, Minnesota, United States
Contact: Camerone Bey    612-813-7628      
Principal Investigator: Andrea Hoogerland, MD         
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

No publications provided

Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT01287052     History of Changes
Other Study ID Numbers: 1101-006
Study First Received: January 28, 2011
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014