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.
|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|
- 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 ]
|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)|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287052
|Contact: Andrea Hoogerland, MDfirstname.lastname@example.org|
|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|
|Principal Investigator:||Andrea Hoogerland, MD||Children's Hospitals and Clinics of Minnesota|