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Intranasal Lidocaine in Acute Management of Pediatric Migraine and Migraine-like Headache

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ClinicalTrials.gov Identifier: NCT03806595
Recruitment Status : Not yet recruiting
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Garth Meckler, University of British Columbia

Brief Summary:
Headaches in children are very common and are a source of significant distress for the patient and their family. Migraines are the most common headache disorder in children and are associated with episodic pain and other symptoms such as nausea and sensitivity to light and sound that can impair a child's ability to participate in daily activities and lead to missed school or parental missed work. When home treatment fails to relieve symptoms, children often seek care in the emergency department (ED) where a limited number of treatment options exist; while largely effective, these rescue treatments currently all require needle insertion of an intravenous line, take time to administer, result in prolonged ED stays, and have potential unpleasant side effects. In adult patients, a number of studies suggest that lidocaine, a local anesthetic (numbing medication) administered as a mist sprayed in the nose (intranasal administration), may provide relief of migraine and migraine-like headache pain in minutes. This approach has the benefit of working quickly, not requiring a needle, and having fewer side effects as the medication acts locally on nerves in the nose. Intranasal lidocaine has not yet been studied in children. This study will compare the use of intranasal lidocaine to the standard intravenous medications used in the study institution. The investigators will evaluate its effectiveness in reducing pain, decreasing the length of emergency department stay, and overall safety for children. The investigators hypothesize that children receiving intranasal lidocaine will have faster and more effective pain recovery compared to children receiving placebo and will be less likely to require the standard therapy for migraine headache. Given very few side effects reported in adult studies and the relatively benign nature of those reported, the investigators do not expect any major safety concerns in the study. It is also hypothesized that intranasal lidocaine will lead to shorter ED visits, thus reducing use of staff and hospital resources and saving money for the healthcare system as a whole.

Condition or disease Intervention/treatment Phase
Migraine in Children Posttraumatic Headache Drug: Lidocaine 2% Injectable Solution Drug: Normal Saline Flush, 0.9% Injectable Solution Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Intranasal Lidocaine in Acute Management of Pediatric Migraine and Migraine-like Headache: A Randomized Controlled Trial
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : September 4, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Intranasal lidocaine
1mL of lidocaine 2% will be instilled in either the nostril ipsilateral to the headache or 1ml in each nostril in cases of bilateral headache.
Drug: Lidocaine 2% Injectable Solution
The Barre method of intranasal administration will be used to instil 1mL of lidocaine 2% in either the nostril ipsilateral to the headache or 1ml in each nostril in cases of bilateral headache.

Placebo Comparator: Intranasal normal saline
1mL of saline 0.9% will be instilled in either the nostril ipsilateral to the headache or 1ml in each nostril in cases of bilateral headache.
Drug: Normal Saline Flush, 0.9% Injectable Solution
The Barre method of intranasal administration will be used to instil 1mL of saline 0.9% in either the nostril ipsilateral to the headache or 1ml in each nostril in cases of bilateral headache.




Primary Outcome Measures :
  1. Change in migraine pain [ Time Frame: Pain scores will be measured at 30 and 60 minutes post intranasal administration of either the study drug or placebo. ]
    The primary outcome measure will be the proportion of subjects with numeric pain scores of < 4 out of 10 on a verbal rating scale (range 0 -10 with increasing severity, i.e. 0 = no pain and 10 = most severe pain).Treatment success is defined as a score of 3 or less at the two time points. This will be recorded for each patient during the study timeframe, until study completion.


Secondary Outcome Measures :
  1. Rebound headache [ Time Frame: Pain scores will be recorded at 60 minutes, 24 hours, and within 48-72 hours post intranasal therapy. ]
    Proportion of patients with rebound headache (i.e. headache with pain score of greater than or equal to 4 out of 10 on a verbal rating scale; range 0 -10 with increasing severity, i.e. 0 = no pain and 10 = most severe pain). This will be recorded for each patient at the visit of interest during the study timeframe, until study completion.

  2. Emergency department length of stay [ Time Frame: The emergency department length of stay will be ascertained from the medical record within 24 hours of the participant's visit. ]
    Number of hours in the Emergency Department from time of registration to time of discharge or admission to hospital for each subject.

  3. Proportion of participants discharged vs. admitted from the emergency department (emergency department disposition) [ Time Frame: Disposition will be ascertained from the medical record within 24 hours of the participant's ED visit. ]
    Disposition of the patient from the emergency department for the visit of interest only, i.e. discharge home, hospital admission. This will be recorded for each patient during the study timeframe, until study completion.

  4. Proportion of participants with a return visit to the emergency department within 72 hours of discharge. [ Time Frame: Within 3 days from index visit. ]
    Returns to the emergency department for similar complaints of migraine headache or posttraumatic headache with migraine like features.



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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Children aged 7-16 years
  2. Migraine headache fulfilling Irma's criteria:

    • Headache lasting 1-72 hours with at least 4 out of 6 of the following features:

      • Moderate to severe episode of impaired daily activities
      • Focal localization of headache
      • Pulsatile description
      • Nausea or vomiting or abdominal pain
      • Photophobia, phonophobia, or avoidance of light and noise, or
      • Symptoms increasing with activity or resolving by rest.

    OR:

  3. Post-traumatic headache as per ICHD-3 (beta edition) definition with migraine-like features (see above):

    • Any headache fulfilling criteria C and D
    • Traumatic injury to the head has occurred
    • Headache is reported to have developed within 7 days after one of the following: • The injury to the head,

      • Regaining of consciousness following the injury to the head,
      • Discontinuation of medication(s) that impair ability to sense or report headache following the injury to the head
    • Headache persists for > 3 months after the injury to the head
    • Not better accounted for by another ICHD-3 diagnosis
  4. Verbal report of a pain score of 4 or greater on a 10 point numeric pain score (range 0-10 with increasing severity, i.e. 0 = no pain and 10 = most severe pain) after receiving first line therapy (non-narcotic analgesia) in either the out-patient or PED setting
  5. Normal vital signs for age
  6. Normal neurological exam (no focal deficits or abnormalities)

Exclusion Criteria:

  1. Families not providing informed consent or assent, where appropriate
  2. History of acute trauma or seizure in the preceding 24 hours
  3. Clinical suspicion of or known intracranial pathology or underlying central nervous system disease
  4. Headache associated with fever or meningismus
  5. Known allergy/sensitivity to lidocaine

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): NCT03806595


Contacts
Contact: Kate Maki, MD 7786890687 kate.maki@cw.bc.ca
Contact: Garth Meckler, MD 6047215550 garth.meckler@cw.bc.ca

Locations
Canada, British Columbia
BC Children's Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V6H 3N1
Contact: Nur Eisma    604-875-2427    neisma@bcchr.ubc.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Garth Meckler, MD University of British Columbia

Responsible Party: Garth Meckler, Pediatric Emergency Medicine Division Head, University of British Columbia
ClinicalTrials.gov Identifier: NCT03806595     History of Changes
Other Study ID Numbers: H18-03801
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Migraine Disorders
Headache
Post-Traumatic Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Secondary
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