Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department

Conditions
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Migraine

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: non-occipital location of headache (frontal, frontotemporal, or unilateral) pulsating or throbbing quality aggravated by or causing avoidance of routine physical activity nausea, vomiting, or both 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>Subjects will receive a one time dose of 20mg of 2% lidocaine (1 mL) via nasal mucosal atomizer | Drug: Lidocaine<br>* 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.<br>* Other names: 2% Lidocaine Hydrochloride Solution (20 mg/mL);|
| Placebo Comparator: Placebo<br>Subjects will receive a one time dose of 1 mL of 0.9% sodium chloride solution via nasal mucosal atomizer. | Drug: Placebo<br>* 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.<br>* Other names: 0.9% sodium chloride solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Score | 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 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Subjects with Improvement of Associated Symptoms | 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. | Prior to study drug administration at baseline and 20 minutes after study drug administration. | 
| The Number of Subjects Who Receive IV Pain Medications | 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. | 1 hour | 
| The Number of Subjects with Rebound headache | Each subject will be asked to respond yes or no if their headache returned at 1 hour post study drug administration. | 1 hour. | 
| The Number of Subjects with Rebound headache after discharge | Each subject will be called within 1 week of discharge and asked to respond yes or no if they had rebound headache. | 1 week | 
| The Number of Patients that Would Use Their Intranasal Medication the Next Time They Have a Migraine | 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 | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, intranasal lidocaine, migraine, headache, emergency department, pain