Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York City Health and Hospitals Corporation
• Treatments: Lidocaine; Pharmaceutical Solutions

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