Migraine in ChildrenPhase 1NCT03806595
A Pilot Study of Intranasal Lidocaine in Acute Management of Pediatric Migraine
A Phase 1 study testing Lidocaine 2% Injectable Solution and Normal Saline Flush, 0.9% Injectable Solution in people with Migraine in Children and Posttraumatic Headache, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine in Children, Posttraumatic Headache
- What is being tested?
- Lidocaine 2% Injectable Solution and Normal Saline Flush, 0.9% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jul 2019to 3 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 7-16 years
- 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
Show all 20Show fewer
- Nausea or vomiting or abdominal pain
- Photophobia, phonophobia, or avoidance of light and noise, or
- Symptoms increasing with activity or resolving by rest.
- OR:
- 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, ii. Regaining of consciousness following the injury to the head, iii. 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
- 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
- Normal vital signs for age
- Normal neurological exam (no focal deficits or abnormalities)
Who cannot join
- Families not providing informed consent or assent, where appropriate
- History of acute trauma or seizure in the preceding 24 hours
- Clinical suspicion of or known intracranial pathology or underlying central nervous system disease
- Headache associated with fever or meningismus
- Known allergy/sensitivity to lidocaine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Intranasal Lidocaine in Acute Management of Pediatric Migraine and Migraine-like Headache: A Randomized Controlled Trial
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 administered intranasally, 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 for this purpose. This study will compare the use of intranasal lidocaine to placebo. The goal of this pilot study is to provide information to inform the sample size calculation for the definitive randomized controlled trial that will aim to measure the efficacy of intranasal lidocaine as an analgesic option for children age 7 years and older who present to the Pediatric ED with a chief complaint of migraine or post traumatic headache with migraine-like features. Secondary objectives will be to report on the frequency and severity of rebound headache between the two treatment groups, adverse events of the study drug, as well as the impact on healthcare utilization measures.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.
- Conditions
- Migraine in Children, Posttraumatic Headache
- Being tested
- Lidocaine 2% Injectable Solution, Normal Saline Flush, 0.9% Injectable Solution
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2% Injectable SolutionDrug
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.
Normal Saline Flush, 0.9% Injectable SolutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal lidocaine | Experimental | 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. Receives: Drug: Lidocaine 2% Injectable Solution |
| Intranasal normal saline | Placebo comparator | 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. Receives: Drug: Normal Saline Flush, 0.9% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in migraine pain
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.
Measured: Pain scores will be measured at 30 and 60 minutes post intranasal administration of either the study drug or placebo.
Secondary outcomes (4)
Rebound headache
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.
Measured: Pain scores will be recorded at 60 minutes, 24 hours, and within 48-72 hours post intranasal therapy.
Emergency department length of stay
Number of hours in the Emergency Department from time of registration to time of discharge or admission to hospital for each subject.
Measured: The emergency department length of stay will be ascertained from the medical record within 24 hours of the participant's visit.
Proportion of participants discharged vs. admitted from the emergency department (emergency department disposition)
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.
Measured: Disposition will be ascertained from the medical record within 24 hours of the participant's ED visit.
Proportion of participants with a return visit to the emergency department within 72 hours of discharge.
Returns to the emergency department for similar complaints of migraine headache or posttraumatic headache with migraine like features.
Measured: Within 3 days from index visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start3 Jul 2019
- Primary completion3 Dec 2020
- Study completion3 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine in ChildrenStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garth Meckler, University of British Columbia
- Investigators
- Garth Meckler, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806595
- Sponsor's protocol ID
- H18-03801
- Status last verified
- Apr 2021
- First submitted
- 23 Nov 2018
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Intranasal Lidocaine in Acute Management of Pediatric Migraine and Migraine-like Headache: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03806595
- Acronym / sponsor ID
- H18-03801
- Conditions
- Migraine in Children, Posttraumatic Headache
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 administered intranasally, 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 for this purpose. This study will compare the use of intranasal lidocaine to placebo. The goal of this pilot study is to provide information to inform the sample size calculation for the definitive randomized controlled trial that will aim to measure the efficacy of intranasal lidocaine as an analgesic option for children age 7 years and older who present to the Pediatric ED with a chief complaint of migraine or post traumatic headache with migraine-like features. Secondary objectives will be to report on the frequency and severity of rebound headache between the two treatment groups, adverse events of the study drug, as well as the impact on healthcare utilization measures.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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal lidocaine | Experimental | Drug: Lidocaine 2% Injectable Solution1mL of lidocaine 2% will be instilled in either the nostril ipsilateral to the headache or 1ml in each nostril in cases of bilateral headache. |
| Intranasal normal saline | Placebo comparator | Drug: Normal Saline Flush, 0.9% Injectable Solution1mL 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. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (20 listed)
- Children aged 7-16 years
- Migraine headache fulfilling Irma's criteria:
- Post-traumatic headache as per ICHD-3 (beta edition) definition with migraine-like features (see above):
- 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
- Normal vital signs for age
Key exclusion criteria (5 listed)
- Families not providing informed consent or assent, where appropriate
- History of acute trauma or seizure in the preceding 24 hours
- Clinical suspicion of or known intracranial pathology or underlying central nervous system disease
- Headache associated with fever or meningismus
- Known allergy/sensitivity to lidocaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 2% Injectable SolutionThe 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. | Drug | Intranasal lidocaine |
| Normal Saline Flush, 0.9% Injectable SolutionThe 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. | Drug | Intranasal normal saline |
Primary outcome
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.
4 secondary outcomes
Rebound headache
Time frame: Pain scores will be recorded at 60 minutes, 24 hours, and within 48-72 hours post intranasal therapy.
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.
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.
Proportion of participants with a return visit to the emergency department within 72 hours of discharge.
Time frame: Within 3 days from index visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garth Meckler, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lidocaine 2% Injectable Solution and Normal Saline Flush, 0.9% Injectable Solution in people with Migraine in Children and Posttraumatic Headache, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.