Nitrous Oxide for Acute Migraine Pain in the Emergency Room (ED)
This study is currently recruiting participants.
Verified August 2012 by Children's Hospitals and Clinics of Minnesota
Sponsor:
Children's Hospitals and Clinics of Minnesota
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT01287052
First received: January 28, 2011
Last updated: August 8, 2012
Last verified: August 2012
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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:
Genetics Home Reference related topics:
familial hemiplegic migraine
Drug Information available for:
Nitrous oxide
U.S. FDA Resources
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: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (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
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: | August 8, 2012 |
| 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 Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 16, 2013