MigrainePhase 3NCT03576820
Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department
A Phase 3 study testing Lidocaine in people with Migraine, run by New York City Health and Hospitals Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to Dec 2022
- Phase
- Phase 3
- 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 10 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
- non-occipital location of headache (frontal, frontotemporal, or unilateral)
- pulsating or throbbing quality
Show all 9Show fewer
- aggravated by or causing avoidance of routine physical activity
- nausea, vomiting, or both
- photophobia and/or phonophobia (may be inferred from behavior)
Who cannot join
- unstable vital signs
- pregnancy
- lactating
- altered mental status
- developmental delay
- intractable vomiting
Show all 10Show fewer
- first-time headache
- history of cardiac arrythmia
- previous adverse reaction or allergy to lidocaine
- non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Jacobi Medical Center
The Bronx, New York, 10461
Wende Gelb, MD, 718-918-5312, gelbw@nychhc.org
Katherine Chou, MD, 718-918-5312, katherine.chou@nychhc.org
About this study
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called 2% Lidocaine Hydrochloride Solution (20 mg/mL)
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.
PlaceboDrug
Also called 0.9% sodium chloride solution
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.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Subjects will receive a one time dose of 20mg of 2% lidocaine (1 mL) via nasal mucosal atomizer Receives: Drug: Lidocaine |
| Placebo | Placebo comparator | Subjects will receive a one time dose of 1 mL of 0.9% sodium chloride solution via nasal mucosal atomizer. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score
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.
Measured: 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 outcomes (5)
The Number of Subjects with Improvement of Associated Symptoms
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.
Measured: Prior to study drug administration at baseline and 20 minutes after study drug administration.
The Number of Subjects Who Receive IV Pain Medications
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.
Measured: 1 hour
The Number of Subjects with Rebound headache
Each subject will be asked to respond "yes" or "no" if their headache returned at 1 hour post study drug administration.
Measured: 1 hour.
The Number of Subjects with Rebound headache after discharge
Each subject will be called within 1 week of discharge and asked to respond "yes" or "no" if they had rebound headache.
Measured: 1 week
The Number of Patients that Would Use Their Intranasal Medication the Next Time They Have a Migraine
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start15 Oct 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York City Health and Hospitals Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Chou, MD, Principal investigator, New York City Health and Hospitals Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576820
- Sponsor's protocol ID
- 2018-9278
- Status last verified
- Dec 2020
- First submitted
- 8 Jun 2018
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barzegari H, Motamed H, Ziapour B, Hajimohammadi M, Kadkhodazadeh M. Intranasal Lidocaine for Primary Headache Management in Emergency Department; a Clinical Trial. Emerg (Tehran). 2017;5(1):e79. Epub 2017 Sep 16.
PubMed 29201961Smith D, Cheek H, Denson B, Pruitt CM. Lidocaine Pretreatment Reduces the Discomfort of Intranasal Midazolam Administration: A Randomized, Double-blind, Placebo-controlled Trial. Acad Emerg Med. 2017 Feb;24(2):161-167. doi: 10.1111/acem.13115. Epub 2017 Jan 30.
PubMed 27739142Yaeger J. Adding intranasal lidocaine to midazolam may benefit children undergoing procedural sedation. J Pediatr. 2011 Jul;159(1):166. doi: 10.1016/j.jpeds.2011.05.010. No abstract available.
PubMed 21669320Chiaretti A, Barone G, Rigante D, Ruggiero A, Pierri F, Barbi E, Barone G, Riccardi R. Intranasal lidocaine and midazolam for procedural sedation in children. Arch Dis Child. 2011 Feb;96(2):160-3. doi: 10.1136/adc.2010.188433. Epub 2010 Oct 27.
PubMed 21030365Maizels M, Geiger AM. Intranasal lidocaine for migraine: a randomized trial and open-label follow-up. Headache. 1999 Sep;39(8):543-51. doi: 10.1046/j.1526-4610.1999.3908543.x.
PubMed 11279969Maizels M. Intranasal lidocaine to prevent headache following migraine aura. Headache. 1999 Jun;39(6):439-42. doi: 10.1046/j.1526-4610.1999.3906439.x.
PubMed 11279923Kabbouche M. Management of Pediatric Migraine Headache in the Emergency Room and Infusion Center. Headache. 2015 Nov-Dec;55(10):1365-70. doi: 10.1111/head.12694. Epub 2015 Oct 21.
PubMed 26486800Richer LP, Laycock K, Millar K, Fitzpatrick E, Khangura S, Bhatt M, Guimont C, Neto G, Noseworthy S, Siemens R, Gouin S, Rowe BH; Pediatric Emergency Research Canada Emergency Department Migraine Group. Treatment of children with migraine in emergency departments: national practice variation study. Pediatrics. 2010 Jul;126(1):e150-5. doi: 10.1542/peds.2009-2337. Epub 2010 Jun 7.
PubMed 20530076Patterson-Gentile C, Szperka CL. The Changing Landscape of Pediatric Migraine Therapy: A Review. JAMA Neurol. 2018 Jul 1;75(7):881-887. doi: 10.1001/jamaneurol.2018.0046.
PubMed 29532087Brousseau DC, Duffy SJ, Anderson AC, Linakis JG. Treatment of pediatric migraine headaches: a randomized, double-blind trial of prochlorperazine versus ketorolac. Ann Emerg Med. 2004 Feb;43(2):256-62. doi: 10.1016/s0196-0644(03)00716-9.
PubMed 14747817Prensky AL, Sommer D. Diagnosis and treatment of migraine in children. Neurology. 1979 Apr;29(4):506-10. doi: 10.1212/wnl.29.4.506.
PubMed 571549Kudrow L, Kudrow DB, Sandweiss JH. Rapid and sustained relief of migraine attacks with intranasal lidocaine: preliminary findings. Headache. 1995 Feb;35(2):79-82. doi: 10.1111/j.1526-4610.1995.hed3502079.x.
PubMed 7737865
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department
- ClinicalTrials.gov ID
- NCT03576820
- Acronym / sponsor ID
- 2018-9278
- Conditions
- Migraine
- Keywords
- pediatrics, intranasal lidocaine, migraine, headache, emergency department, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- New York City Health and Hospitals CorporationUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 3 Jul 2018 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: LidocaineSubjects will receive a one time dose of 20mg of 2% lidocaine (1 mL) via nasal mucosal atomizer |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive a one time dose of 1 mL of 0.9% sodium chloride solution via nasal mucosal atomizer. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (10 listed)
- unstable vital signs
- pregnancy
- lactating
- altered mental status
- developmental delay
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 |
|---|---|---|
| LidocaineAlso: 2% Lidocaine Hydrochloride Solution (20 mg/mL)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. | Drug | Lidocaine |
| PlaceboAlso: 0.9% sodium chloride solutionBaseline 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. | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
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 Number of Subjects Who Receive IV Pain Medications
Time frame: 1 hour
The Number of Subjects with Rebound headache
Time frame: 1 hour.
The Number of Subjects with Rebound headache after discharge
Time frame: 1 week
The Number of Patients that Would Use Their Intranasal Medication the Next Time They Have a Migraine
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Background: PubMed 29201961Barzegari H, Motamed H, Ziapour B, Hajimohammadi M, Kadkhodazadeh M. Intranasal Lidocaine for Primary Headache Management in Emergency Department; a Clinical Trial. Emerg (Tehran). 2017;5(1):e79. Epub 2017 Sep 16.
- Background: PubMed 27739142Smith D, Cheek H, Denson B, Pruitt CM. Lidocaine Pretreatment Reduces the Discomfort of Intranasal Midazolam Administration: A Randomized, Double-blind, Placebo-controlled Trial. Acad Emerg Med. 2017 Feb;24(2):161-167. doi: 10.1111/acem.13115. Epub 2017 Jan 30.
- Background: PubMed 21669320Yaeger J. Adding intranasal lidocaine to midazolam may benefit children undergoing procedural sedation. J Pediatr. 2011 Jul;159(1):166. doi: 10.1016/j.jpeds.2011.05.010. No abstract available.
- Background: PubMed 21030365Chiaretti A, Barone G, Rigante D, Ruggiero A, Pierri F, Barbi E, Barone G, Riccardi R. Intranasal lidocaine and midazolam for procedural sedation in children. Arch Dis Child. 2011 Feb;96(2):160-3. doi: 10.1136/adc.2010.188433. Epub 2010 Oct 27.
- Background: PubMed 11279969Maizels M, Geiger AM. Intranasal lidocaine for migraine: a randomized trial and open-label follow-up. Headache. 1999 Sep;39(8):543-51. doi: 10.1046/j.1526-4610.1999.3908543.x.
- Background: PubMed 11279923Maizels M. Intranasal lidocaine to prevent headache following migraine aura. Headache. 1999 Jun;39(6):439-42. doi: 10.1046/j.1526-4610.1999.3906439.x.
- Background: PubMed 26486800Kabbouche M. Management of Pediatric Migraine Headache in the Emergency Room and Infusion Center. Headache. 2015 Nov-Dec;55(10):1365-70. doi: 10.1111/head.12694. Epub 2015 Oct 21.
- Background: PubMed 20530076Richer LP, Laycock K, Millar K, Fitzpatrick E, Khangura S, Bhatt M, Guimont C, Neto G, Noseworthy S, Siemens R, Gouin S, Rowe BH; Pediatric Emergency Research Canada Emergency Department Migraine Group. Treatment of children with migraine in emergency departments: national practice variation study. Pediatrics. 2010 Jul;126(1):e150-5. doi: 10.1542/peds.2009-2337. Epub 2010 Jun 7.
- Background: PubMed 29532087Patterson-Gentile C, Szperka CL. The Changing Landscape of Pediatric Migraine Therapy: A Review. JAMA Neurol. 2018 Jul 1;75(7):881-887. doi: 10.1001/jamaneurol.2018.0046.
- Background: PubMed 14747817Brousseau DC, Duffy SJ, Anderson AC, Linakis JG. Treatment of pediatric migraine headaches: a randomized, double-blind trial of prochlorperazine versus ketorolac. Ann Emerg Med. 2004 Feb;43(2):256-62. doi: 10.1016/s0196-0644(03)00716-9.
- Background: PubMed 571549Prensky AL, Sommer D. Diagnosis and treatment of migraine in children. Neurology. 1979 Apr;29(4):506-10. doi: 10.1212/wnl.29.4.506.
- Background: PubMed 7737865Kudrow L, Kudrow DB, Sandweiss JH. Rapid and sustained relief of migraine attacks with intranasal lidocaine: preliminary findings. Headache. 1995 Feb;35(2):79-82. doi: 10.1111/j.1526-4610.1995.hed3502079.x.
- 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.
Katherine Chou, MD principal investigator
New York City Health and Hospitals Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine in people with Migraine, run by New York City Health and Hospitals Corporation at 1 site in United States.
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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 5 Jan 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wende Gelb, MD (718-918-5312, gelbw@nychhc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03576820, which also lists 12 linked publications.
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 5 Jan 2021.