Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department

December 31, 2020 updated by: New York City Health and Hospitals Corporation
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Recruiting
        • Jacobi Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katherine Chou, MD
        • Sub-Investigator:
          • Wende Gelb, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lidocaine
Subjects will receive a one time dose of 20mg of 2% lidocaine (1 mL) via nasal mucosal atomizer
Drug: 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.
Other Names:
  • 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.
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.
Other Names:
  • 0.9% sodium chloride solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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
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.
Prior to study drug administration at baseline and 20 minutes after study drug administration.
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.
1 hour
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.
1 hour.
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.
1 week
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
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York City Health and Hospitals Corporation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2018

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 8, 2018

First Submitted That Met QC Criteria

June 21, 2018

First Posted (Actual)

July 3, 2018

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 31, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-9278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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