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Bronx, New York 10461


Purpose:

The purpose of the study is to determine the effect of intranasal lidocaine on pain score in pediatric patients with migraine. Patients with significant pain after oral analgesics and plan for intravenous (IV) abortive therapy will be asked to participate. Half of patients will be given intranasal lidocaine and the other half will be given placebo. Pain scores and associated migraine symptoms (i.e. nausea, vomiting, photophobia, phonophobia, avoidance of activities, and aura) will be monitored and compared between the groups.


Study summary:

This will be a double-blinded, randomized-controlled trial using intranasal lidocaine to provide fast-acting pain relief in pediatric patients presenting with migraine to an urban pediatric emergency department (ED). Typically, abortive therapy for migraine in many emergency departments begins with oral analgesics such as ibuprofen and acetaminophen. However, many patients with inadequate pain relief after oral analgesics will require intravenous (IV) medications to abort their migraine symptoms. These medications can take up to thirty minutes or more for the onset of action to begin, potentially leaving patients in significant pain during that time. Also, obtaining IV access in children can be time-consuming and technically difficult, further delaying time to pain relief. Subjects will be given either intranasal lidocaine or placebo while awaiting IV placement and IV metoclopramide administration. Pain scales and associated migraine symptoms will be compared between the two arms before study medication administration and again at 5, 10, and 20 minutes.


Criteria:

Inclusion Criteria: - Patients who will be receiving IV metoclopramide because their migraine is refractory to oral analgesics, as determined by the treating physician. - Moderate to severe headache with NRS score greater than or equal to 6 - Headache lasting between 2-72 hours - Two of the following: 1. non-occipital location of headache (frontal, frontotemporal, or unilateral) 2. pulsating or throbbing quality 3. aggravated by or causing avoidance of routine physical activity 4. nausea, vomiting, or both 5. photophobia and/or phonophobia (may be inferred from behavior) Exclusion Criteria: - unstable vital signs - pregnancy - lactating - altered mental status - developmental delay - intractable vomiting - first-time headache - history of cardiac arrythmia - previous adverse reaction or allergy to lidocaine - non-English speaking


NCT ID:

NCT03576820


Primary Contact:

Principal Investigator
Katherine Chou, MD
New York City Health and Hospitals Corporation

Wende Gelb, MD
Phone: 718-918-5312
Email: gelbw@nychhc.org


Backup Contact:

Email: katherine.chou@nychhc.org
Katherine Chou, MD
Phone: 718-918-5312


Location Contact:

Bronx, New York 10461
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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