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

January 28, 2011
April 21, 2014
June 2011
August 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01287052 on ClinicalTrials.gov Archive Site
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Not Provided
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Nitrous Oxide for Acute Migraine Pain in the Emergency Room (ED)
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.

Not Provided
Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Migraine
  • Pain
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.
Experimental: Nitrous Oxide
Intervention: Drug: Nitrous Oxide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
8 Years to 18 Years
No
Contact: Andrea Hoogerland, MD 612-813-3300 andrea.hoogerland@childrensmn.org
United States
 
NCT01287052
1101-006
No
Children's Hospitals and Clinics of Minnesota
Children's Hospitals and Clinics of Minnesota
Not Provided
Principal Investigator: Andrea Hoogerland, MD Children's Hospitals and Clinics of Minnesota
Children's Hospitals and Clinics of Minnesota
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP