Nitrous Oxide for Acute Migraine Pain in the Emergency Room (ED)
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|ClinicalTrials.gov Identifier: NCT01287052|
Recruitment Status : Completed
First Posted : February 1, 2011
Last Update Posted : July 30, 2015
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 or disease||Intervention/treatment||Phase|
|Migraine Pain||Drug: Nitrous Oxide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nitrous Oxide for Acute Pediatric Migraine Pain Management in the Emergency Room|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||January 2015|
|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.
- Decrease in the acute migraine pain in children and adolescents presenting to an Emergency Department [ Time Frame: within 48 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287052
|United States, Minnesota|
|Children's Hospitals and Clinics of Minnesota|
|Minneapolis, Minnesota, United States|
|Principal Investigator:||Andrea Hoogerland, MD||Children's Hospitals and Clinics of Minnesota|