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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
Sponsor:
Information provided by (Responsible Party):
New York City Health and Hospitals Corporation

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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Lidocaine Drug: Placebo Phase 3

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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 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.
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 Name: 0.9% sodium chloride solution




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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



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Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
Contact: Wende Gelb, MD 718-918-5312 gelbw@nychhc.org
Contact: Katherine Chou, MD 718-918-5312 katherine.chou@nychhc.org

Locations
United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
New York City Health and Hospitals Corporation
Investigators
Principal Investigator: Katherine Chou, MD New York City Health and Hospitals Corporation

Publications:

Responsible Party: New York City Health and Hospitals Corporation
ClinicalTrials.gov Identifier: NCT03576820     History of Changes
Other Study ID Numbers: 2018-9278
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by New York City Health and Hospitals Corporation:
pediatrics
intranasal lidocaine
migraine
headache
emergency department
pain

Additional relevant MeSH terms:
Migraine Disorders
Emergencies
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pharmaceutical Solutions
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action