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

NCT01287052 | Completed

• 1 other identifier: 1101-006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine; Pain

Keywords

Migraine; Pediatric; Adolescent; Nitrous Oxide

Outcome Measures

Primary Outcomes (1)

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

  within 48 hours

Study Arms (1)

Nitrous Oxide

EXPERIMENTAL

Drug: Nitrous Oxide

Interventions

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.

Nitrous Oxide

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Pain

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Officials

• Andrea Hoogerland, MD

  Children's Hospitals and Clinics of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2011
• First Posted: February 1, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: January 1, 2015
• Last Updated: July 30, 2015

Record last verified: 2014-04

Locations

US (1)