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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitrous Oxide

Drug

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 outcomes

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

Time frame: within 48 hours

Sponsors and collaborators

Lead sponsor

Children's Hospitals and Clinics of Minnesota

Other

Registry information

Official study title

Nitrous Oxide for Acute Pediatric Migraine Pain Management in the Emergency Room

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2015
First posted: Feb 1, 2011
Registry last updated: Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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