Migraine in ChildrenPhase 3NCT03984045
SPG Block for Acute Pediatric Migraine
A Phase 3 study testing Lidocaine topical and Prochlorperazine Injection in people with Migraine in Children and Sphenopalatine Neuralgia, run by Newark Beth Israel Medical Center at 1 site in United States.
Trial summary
This is a randomized double blind trial comparing an intranasal sphenopalatine block with 2% lidocaine to intravenous (0.15 mg/kg, max 10mg) prochlorperazine in patients greater than 10 years of age presenting to a pediatric emergency department with an acute frontal migraine headache. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Migraine in Children, Sphenopalatine Neuralgia, Migraine in Adolescence
- What is being tested?
- Lidocaine topical and Prochlorperazine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2019to 30 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- Frontal migraine headache
Who cannot join
- Non-english speaking
- Known pregnancy
- Sickle cell hemaglobinopathy
- Concern for CNS infection
- Acute febrile illness
- non-frontal headaches
- Concern for increased intracranial pressure
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Adam Sivitz, MD, 973-926-2484, adam.sivitz@rwjbh.org
About this study
Official title: Sphenopalatine Ganglion Block for Treating Acute Frontal Migraine Headache in Pediatric Patients
This is a randomized double blind trial comparing an intranasal sphenopalatine block with 2% lidocaine to intravenous (0.15 mg/kg, max 10mg) prochlorperazine in patients greater than 10 years of age presenting to a pediatric emergency department with an acute frontal migraine headache.
Read the detailed description
This is a randomized double blind trial comparing an intranasal sphenopalatine block with 2% lidocaine to intravenous (0.15 mg/kg, max 10mg) prochlorperazine in patients greater than 10 years of age presenting to a pediatric emergency department with an acute frontal migraine headache. Excluded populations include those with sickle cell, concern for CNS infection
- Being tested
- Lidocaine topical, Prochlorperazine Injection
- Medical subject headings
- Facial Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine topicalDrug
Intranasal 2% lidocaine delivered directly to SPG
Prochlorperazine InjectionDrug
intravenous prochlorperazine at 0.15mg/kg max 10 mg
| Study group | Role | What they receive |
|---|---|---|
| SPG block | Experimental | SPG block performed by using qtip applicator soaked in 2% lidocaine and placed posteriorly into nasal cavity where it dwells for up to 30 min Receives: Drug: Lidocaine topical |
| Control | Active comparator | Delivered through IV access obtained in all patients. Receives: Drug: Prochlorperazine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to headache resolution
Time to headache resolution in emergency department
Measured: treatment start to patient reported resolution, up to 6 hours
ED Length of stay
treatment to discharge
Measured: Registration to discharge up to 6 hours
Secondary outcomes (4)
Patient satisfaction: Rated on a Likert 100 millimeter scale
Patient satisfaction as determined by whether they would absolutely want treatment again (score=100), or would absolutely prefer another method (score = 0), or something in between (any mark along the 100 millimeter line)
Measured: Within 6 hours from ED registration
24 hr follow up
Presence of headache at 24 hrs
Measured: 1 day
Number of participants with treatment induced side effects
Recording appearance of any side effects in ED or within 24 hr follow up, such as nausea, vomiting, neck stiffness, seizure, or prolonged (greater than 6hrs) numbness.
Measured: 1 day
Determine adequacy of blinding
Determine whether treating physicians or patients can guess treatment arm (IN or IV arm) by simply asking the blinded patient and clinician which method they think the patient underwent. Measured by guessing one or the other arm.
Measured: Asked at time of patient discharge from the emergency department or at 1 hr.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start6 Jun 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
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.
- 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newark Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam B Sivitz, MD, Newark Beth Israel Medical Center
- Investigators
- Adam Sivitz, MD, Principal investigator, Newark Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984045
- Sponsor's protocol ID
- 2018.42
- Status last verified
- Nov 2021
- First submitted
- 6 Jun 2019
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphenopalatine Ganglion Block for Treating Acute Frontal Migraine Headache in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03984045
- Acronym / sponsor ID
- 2018.42
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Newark Beth Israel Medical CenterUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 12 Jun 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.
This is a randomized double blind trial comparing an intranasal sphenopalatine block with 2% lidocaine to intravenous (0.15 mg/kg, max 10mg) prochlorperazine in patients greater than 10 years of age presenting to a pediatric emergency department with an acute frontal migraine headache.
Detailed description
This is a randomized double blind trial comparing an intranasal sphenopalatine block with 2% lidocaine to intravenous (0.15 mg/kg, max 10mg) prochlorperazine in patients greater than 10 years of age presenting to a pediatric emergency department with an acute frontal migraine headache. Excluded populations include those with sickle cell, concern for CNS infection
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 |
|---|---|---|
| SPG block | Experimental | Drug: Lidocaine topicalSPG block performed by using qtip applicator soaked in 2% lidocaine and placed posteriorly into nasal cavity where it dwells for up to 30 min |
| Control | Active comparator | Drug: Prochlorperazine InjectionDelivered through IV access obtained in all patients. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Frontal migraine headache
Key exclusion criteria (7 listed)
- Non-english speaking
- Known pregnancy
- Sickle cell hemaglobinopathy
- Concern for CNS infection
- Acute febrile illness
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 topicalIntranasal 2% lidocaine delivered directly to SPG | Drug | SPG block |
| Prochlorperazine Injectionintravenous prochlorperazine at 0.15mg/kg max 10 mg | Drug | Control |
Primary outcome
Time to headache resolution
Time frame: treatment start to patient reported resolution, up to 6 hours
Time to headache resolution in emergency department
ED Length of stay
Time frame: Registration to discharge up to 6 hours
treatment to discharge
4 secondary outcomes
Patient satisfaction: Rated on a Likert 100 millimeter scale
Time frame: Within 6 hours from ED registration
24 hr follow up
Time frame: 1 day
Number of participants with treatment induced side effects
Time frame: 1 day
Determine adequacy of blinding
Time frame: Asked at time of patient discharge from the emergency department or at 1 hr.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 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.
Adam Sivitz, MD principal investigator
Newark Beth Israel Medical Center
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 topical and Prochlorperazine Injection in people with Migraine in Children and Sphenopalatine Neuralgia, run by Newark Beth Israel Medical Center 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 1 inclusion and 7 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 17 Nov 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. 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 Adam Sivitz, MD (973 926 2484, adam.sivitz@rwjbh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to headache resolution (time frame: treatment start to patient reported resolution, up to 6 hours). The study lists 2 primary outcomes in all. 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 17 Nov 2021.