Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department
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|ClinicalTrials.gov Identifier: NCT03576820|
Recruitment Status : Not yet recruiting
First Posted : July 3, 2018
Last Update Posted : July 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: Lidocaine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The medication and placebo doses will be prepared in the pharmacy at the study site and provided to the investigators in deidentified syringes.|
|Official Title:||Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department|
|Estimated Study Start Date :||August 2018|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2019|
Subjects will receive a one time dose of 20mg of 2% lidocaine (1 mL) via nasal mucosal atomizer
Baseline pain score and associated migraine symptoms (such as nausea, vomiting, photophobia, and phonophobia) will be recorded for each subject. Subjects will then receive intranasal lidocaine via atomizer. Pain scores will be reassessed at 5, 10, and 20 minutes. Improvement in associated symptoms will be reassessed at 20 minutes.
Other Name: 2% Lidocaine Hydrochloride Solution (20 mg/mL)
Placebo Comparator: Placebo
Subjects will receive a one time dose of 1 mL of 0.9% sodium chloride solution via nasal mucosal atomizer.
Baseline pain score and associated migraine symptoms (such as nausea, vomiting, photophobia, and phonophobia) will be recorded for each subject. Subjects will then receive 0.9% sodium chloride solution via atomizer. Pain scores will be reassessed at 5, 10, and 20 minutes. Improvement in associated symptoms will be reassessed at 20 minutes.
Other Name: 0.9% sodium chloride solution
- Change in Pain Score [ Time Frame: The NRS will be administered prior to study medication administration at baseline. As well as at 5 minutes, 10 minutes, and 20 minutes after study drug administration. ]The numeric rating scale (NRS) will be used to assess subjects' pain severity. This pain scale is numbered by increments of one, with a minimum score of zero and a maximum score of ten. With zero, as "no pain", and ten as "worst possible pain". We will compare the change of median pain score from baseline to three discrete time points after study medication administration for the patients who receive intranasal lidocaine compared to placebo. For this study, we will assume a decrease in pain score of 3 or more from baseline to any of the post study medication administration time points to be clinically significant.
- The Number of Subjects with Improvement of Associated Symptoms [ Time Frame: Prior to study drug administration at baseline and 20 minutes after study drug administration. ]The presence or absence of nausea, vomiting, photophobia, phonophobia, aura, and avoidance of daily activities will be asked to each subject at baseline. At 20 minutes each subject will be asked to respond "yes" or "no" if each associated symptom has subjectively improved.
- The Number of Subjects Who Receive IV Pain Medications [ Time Frame: 1 hour ]All subjects will be ordered to receive IV metoclopramide. If a subject's pain significantly improved after intranasal drug administration and before IV metoclopramide administration, then metoclopramide will be held, as per discretion of the treating physician. At the end of the study the treating physician will document on the data collection sheet if the subject received IV pain medications.
- The Number of Subjects with Rebound headache [ Time Frame: 1 hour. ]Each subject will be asked to respond "yes" or "no" if their headache returned at 1 hour post study drug administration.
- The Number of Subjects with Rebound headache after discharge [ Time Frame: 1 week ]Each subject will be called within 1 week of discharge and asked to respond "yes" or "no" if they had rebound headache.
- The Number of Patients that Would Use Their Intranasal Medication the Next Time They Have a Migraine [ Time Frame: 1 hour ]At the end of the study all subjects will be asked if they would use their intranasal medication the next time they have a migraine
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): NCT03576820
|Contact: Wende Gelb, MDfirstname.lastname@example.org|
|Contact: Katherine Chou, MDemail@example.com|
|United States, New York|
|Jacobi Medical Center|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Katherine Chou, MD||New York City Health and Hospitals Corporation|