Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department

NCT ID: NCT03576820

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2022-12-31

Brief Summary

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

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lidocaine

Subjects will receive a one time dose of 20mg of 2% lidocaine (1 mL) via nasal mucosal atomizer

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

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.

Placebo

Subjects will receive a one time dose of 1 mL of 0.9% sodium chloride solution via nasal mucosal atomizer.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

Lidocaine

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Other Intervention Names

2% Lidocaine Hydrochloride Solution (20 mg/mL); 0.9% sodium chloride solution

Eligibility 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New York City Health and Hospitals Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine Chou, MD

Role: PRINCIPAL_INVESTIGATOR

New York City Health and Hospitals Corporation

Locations

Jacobi Medical Center

The Bronx, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Wende Gelb, MD

Role: CONTACT

gelbw@nychhc.org

718-918-5312

Katherine Chou, MD

Role: CONTACT

katherine.chou@nychhc.org

718-918-5312

Facility Contacts

Wende Gelb, MD

Role: primary

gelbw@nychhc.org

718-918-5312

Katherine Chou, MD

Role: backup

katherine.chou@nychhc.org

718-918-5312

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

2018-9278

Identifier Type: -

Identifier Source: org_study_id