Migraine DisordersNCT05048914
Migraine Abortive Treatment
An observational study of Migraine Disorders, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
Migraine headaches in children and adolescents may cause severe attacks that require abortive treatment. This study evaluated the incidence and efficacy of medications used for relieving migraine headache attacks in the pediatric population in Israel. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Ibuprofen
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Sep 2019to 1 Jan 2022
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- Child, Adult
Study population: Children 6-18 years of age who were diagnosed with migraine headaches will be enrolled into the study.
Who may be able to join
- children 6-18 years of age with migraine headaches. Need for headache abortive treatment -
Who cannot join
- Secondary headache Systemic disease Mental Retardation
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa, 3104802
Jacob Genizi, MD, 972-4-8359662, genizij@gmail.com
About this study
Official title: Migraine Abortive Treatment in Children and Adolescents in Israel
Migraine headaches in children and adolescents may cause severe attacks that require abortive treatment. This study evaluated the incidence and efficacy of medications used for relieving migraine headache attacks in the pediatric population in Israel. Children 6-18 years of age who were diagnosed in our pediatric neurology clinic as having migraine headaches were enrolled into the study. Children and their parents filled in questionnaires about their response to abortive treatment two hours after use, during three acute headache attacks. The questionnaire included demographic data, baseline headache intensity, migraine-associated symptoms, medications used, and pain assessment.
Read the detailed description
Background: Headaches are a common complaint in children and adolescents. Most cases are caused by a benign problem or a primary headache disorder, such as migraine and tension-type headaches. Not enough research has been done about the effect of analgesics in treating acute primary headache attacks among children.
Study objective-This study's goal is to describe which medications are used for relieving primary headache attacks in outpatient pediatric population in Israel, and to evaluate their analgesic effect.
Methods: The study group will include 50 patients who were assessed in the pediatric neurology clinic and were diagnosed as having a primary headache.
Evaluation of the results via filled out surveys;
- First survey for headache assessment at the pediatric neurology clinic.
- Second survey for tracking given analgesic and its effect by the child at home in addition to checkup calls by pediatric staff.
The survey will include; demographic data, headache diagnosis, baseline headache intensity, antipyretic used and pain assessment.
Research topic:
Use of Common Analgesics in Primary Headaches among Children and Adolescents.
Scientific background:
Headaches are a common complaint in children and adolescents; (1) most cases are caused by a benign problem or a primary headache disorder. Migraine and tension-type headache are the two most common recurring headache patterns seen in children and are distinguished clinically by their characteristics and accompanying features according to the IHS criteria (2).
Treatment of Migraine Frequent Migraine headaches can cause a significant impact on disability, as well as quality of life, prompting the need for early recognition and treatment (3,4,5,6). Thus, the goal of acute treatment of migraine headaches should be a consistent of rapid treatment with minimum side effects and a rapid return to normal function. The most commonly used analgesics are Ibuprofen, and Acetaminophen, and Dipyrone which have shown safety in controlled trials (7). The patient should be instructed to treat the headache as quickly as possible, or at the onset of the aura, if present. Along with treating the acute headache attack, support therapies should be offered by the pediatric neurologist, pediatrician, psychologist, and support groups to reduce the frequency of the attacks.
Acetaminophen and Ibuprofen Efficacy of drugs for the acute treatment of migraine in children has not been studied in well controlled trials. A double-blind crossover study of 88 children was conducted to evaluate the efficacy of Acetaminophen and Ibuprofen, both drugs were shown to be effective and economical treatments for severe to moderate migraine attacks in children. Ibuprofen gave the best relief (8). A similar study was performed on a group of younger children using ibuprofen versus placebo with a similar outcome, although there was a slight male-to-female difference (9).
Dipyrone Dipyrone is used to treat headaches in many countries including Israel. However, it is not available in others, particularly the USA, because of its association with potentially life threatening blood dyscrasias. Its efficacy for the acute treatment of primary headaches in children has not been studied in well controlled trials. Evidence from a small number of trials suggests that Dipyrone is effective for episodic tension-type headache and migraine. No serious adverse events were observed in the included trials, but agranulocytosis is rare and would probably not be observed in such a relatively small sample (10).
In Israel, yet no studies have been initiated to check the efficacy of acute treatment of primary headache attacks among children.
Treatment of TTH Tension type headaches (TTH) are a heterogeneous syndrome, which is diagnosed mainly by the absence of features that are found in other headache types, such as migraine (11). TTH receives much less attention than other types of headache from health authorities, clinical researchers, or industrial pharmacologists. One of the reasons for that may be the fact that most people with infrequent TTH do not consult a doctor for pain relief. They usually manage it themselves using over-the-counter analgesics (12). However, chronic TTH, defined as headache that occurs on 15 days or more per month, is a major health problem with significant educational and socioeconomic effects.
In the case of an acute episode of TTH a gradual strategy is appropriate, as the patients' activity is usually not interrupted and pain intensity is usually not severe (13). In case of repeated, prolonged, or severe episodes of both types of primary headaches, the use of prophylactic treatment should be considered. Pharmacological prophylaxis Life style changes are recommended for young people (1).
Medication overused headaches Medication-overuse headache (MOH) is a chronic headache disorder defined by the International Headache Society as a headache induced by the overuse of analgesics, triptans, or other acute headache compounds. The population-based prevalence of MOH is 0·7% to 1·7%. Most patients with MOH have migraine as their primary headache and overuse triptans or simple analgesics. The pathophysiology of MOH is still unknown. As well as psychological mechanisms such as operant conditioning, changes in endocrinological homoeostasis and neurophysiological changes have been observed in patients with MOH. Recently, a genetic susceptibility has been postulated. In most cases, treatment of MOH consists of abrupt withdrawal therapy and then initiation of an appropriate preventive drug therapy (14).
Purpose of study:
Our goal is to describe which medications are used for relieving primary headache attack in outpatient pediatric population in Israel, and to evaluate their analgesic effect.
Patients and Methods:
The study group will include 50 children 5-18 years of age who were evaluated in the pediatric neurology clinic and were diagnosed as having either migraine or tension type headache. After signing an informed consent the children and/or their parents will be asked to fill a survey about the used of analgesic during acute headache attack, both when they are at the clinic and at home during the headache attack. The surveys will be filled out for a period of 3 months at the first 3 headache episodes. A checkup call by pediatric staff will be performed a month and a half after study initiation, the checkup call's purpose is to make sure the surveys are filled out correctly, follow up and to give medical consultancy when needed. The survey will include; demographic data, headache diagnosis, baseline headache intensity, antipyretic used, dosage, pain assessment at one, three and six-hour time point, migraine-associated symptoms quantification before treatment and at one, three and six-hour time point.
Statistical analysis:
Two-sample t-tests will be performed for continuous variables (headache intensity and treatment) and χ2 for categorical data (such as gender, headache diagnosis). Odds ratios with 95% confidence intervals were computed.
- Conditions
- Migraine Disorders
- Being tested
- Ibuprofen
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called acetaminophen, dipyrone
treatment of acute migraine attack
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine treatment
improvement of headache severity
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start3 Sep 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jacob.genizi, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048914
- Sponsor's protocol ID
- BNZ 095-19
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine Abortive Treatment in Children and Adolescents in Israel
- ClinicalTrials.gov ID
- NCT05048914
- Acronym / sponsor ID
- BNZ 095-19
- Conditions
- Migraine Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 17 Sep 2021 (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.
Migraine headaches in children and adolescents may cause severe attacks that require abortive treatment. This study evaluated the incidence and efficacy of medications used for relieving migraine headache attacks in the pediatric population in Israel. Children 6-18 years of age who were diagnosed in our pediatric neurology clinic as having migraine headaches were enrolled into the study. Children and their parents filled in questionnaires about their response to abortive treatment two hours after use, during three acute headache attacks. The questionnaire included demographic data, baseline headache intensity, migraine-associated symptoms, medications used, and pain assessment.
Detailed description
Background: Headaches are a common complaint in children and adolescents. Most cases are caused by a benign problem or a primary headache disorder, such as migraine and tension-type headaches. Not enough research has been done about the effect of analgesics in treating acute primary headache attacks among children.
Study objective-This study's goal is to describe which medications are used for relieving primary headache attacks in outpatient pediatric population in Israel, and to evaluate their analgesic effect.
Methods: The study group will include 50 patients who were assessed in the pediatric neurology clinic and were diagnosed as having a primary headache.
Evaluation of the results via filled out surveys;
- First survey for headache assessment at the pediatric neurology clinic.
- Second survey for tracking given analgesic and its effect by the child at home in addition to checkup calls by pediatric staff.
The survey will include; demographic data, headache diagnosis, baseline headache intensity, antipyretic used and pain assessment.
Research topic:
Use of Common Analgesics in Primary Headaches among Children and Adolescents.
Scientific background:
Headaches are a common complaint in children and adolescents; (1) most cases are caused by a benign problem or a primary headache disorder. Migraine and tension-type headache are the two most common recurring headache patterns seen in children and are distinguished clinically by their characteristics and accompanying features according to the IHS criteria (2).
Treatment of Migraine Frequent Migraine headaches can cause a significant impact on disability, as well as quality of life, prompting the need for early recognition and treatment (3,4,5,6). Thus, the goal of acute treatment of migraine headaches should be a consistent of rapid treatment with minimum side effects and a rapid return to normal function. The most commonly used analgesics are Ibuprofen, and Acetaminophen, and Dipyrone which have shown safety in controlled trials (7). The patient should be instructed to treat the headache as quickly as possible, or at the onset of the aura, if present. Along with treating the acute headache attack, support therapies should be offered by the pediatric neurologist, pediatrician, psychologist, and support groups to reduce the frequency of the attacks.
Acetaminophen and Ibuprofen Efficacy of drugs for the acute treatment of migraine in children has not been studied in well controlled trials. A double-blind crossover study of 88 children was conducted to evaluate the efficacy of Acetaminophen and Ibuprofen, both drugs were shown to be effective and economical treatments for severe to moderate migraine attacks in children. Ibuprofen gave the best relief (8). A similar study was performed on a group of younger children using ibuprofen versus placebo with a similar outcome, although there was a slight male-to-female difference (9).
Dipyrone Dipyrone is used to treat headaches in many countries including Israel. However, it is not available in others, particularly the USA, because of its association with potentially life threatening blood dyscrasias. Its efficacy for the acute treatment of primary headaches in children has not been studied in well controlled trials. Evidence from a small number of trials suggests that Dipyrone is effective for episodic tension-type headache and migraine. No serious adverse events were observed in the included trials, but agranulocytosis is rare and would probably not be observed in such a relatively small sample (10).
In Israel, yet no studies have been initiated to check the efficacy of acute treatment of primary headache attacks among children.
Treatment of TTH Tension type headaches (TTH) are a heterogeneous syndrome, which is diagnosed mainly by the absence of features that are found in other headache types, such as migraine (11). TTH receives much less attention than other types of headache from health authorities, clinical researchers, or industrial pharmacologists. One of the reasons for that may be the fact that most people with infrequent TTH do not consult a doctor for pain relief. They usually manage it themselves using over-the-counter analgesics (12). However, chronic TTH, defined as headache that occurs on 15 days or more per month, is a major health problem with significant educational and socioeconomic effects.
In the case of an acute episode of TTH a gradual strategy is appropriate, as the patients' activity is usually not interrupted and pain intensity is usually not severe (13). In case of repeated, prolonged, or severe episodes of both types of primary headaches, the use of prophylactic treatment should be considered. Pharmacological prophylaxis Life style changes are recommended for young people (1).
Medication overused headaches Medication-overuse headache (MOH) is a chronic headache disorder defined by the International Headache Society as a headache induced by the overuse of analgesics, triptans, or other acute headache compounds. The population-based prevalence of MOH is 0·7% to 1·7%. Most patients with MOH have migraine as their primary headache and overuse triptans or simple analgesics. The pathophysiology of MOH is still unknown. As well as psychological mechanisms such as operant conditioning, changes in endocrinological homoeostasis and neurophysiological changes have been observed in patients with MOH. Recently, a genetic susceptibility has been postulated. In most cases, treatment of MOH consists of abrupt withdrawal therapy and then initiation of an appropriate preventive drug therapy (14).
Purpose of study:
Our goal is to describe which medications are used for relieving primary headache attack in outpatient pediatric population in Israel, and to evaluate their analgesic effect.
Patients and Methods:
The study group will include 50 children 5-18 years of age who were evaluated in the pediatric neurology clinic and were diagnosed as having either migraine or tension type headache. After signing an informed consent the children and/or their parents will be asked to fill a survey about the used of analgesic during acute headache attack, both when they are at the clinic and at home during the headache attack. The surveys will be filled out for a period of 3 months at the first 3 headache episodes. A checkup call by pediatric staff will be performed a month and a half after study initiation, the checkup call's purpose is to make sure the surveys are filled out correctly, follow up and to give medical consultancy when needed. The survey will include; demographic data, headache diagnosis, baseline headache intensity, antipyretic used, dosage, pain assessment at one, three and six-hour time point, migraine-associated symptoms quantification before treatment and at one, three and six-hour time point.
Statistical analysis:
Two-sample t-tests will be performed for continuous variables (headache intensity and treatment) and χ2 for categorical data (such as gender, headache diagnosis). Odds ratios with 95% confidence intervals were computed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children 6-18 years of age who were diagnosed with migraine headaches will be enrolled into the study.
Key inclusion criteria (1 listed)
- children 6-18 years of age with migraine headaches. Need for headache abortive treatment -
Key exclusion criteria (2 listed)
- Secondary headache Systemic disease Mental Retardation
- -
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 |
|---|---|---|
| IbuprofenAlso: acetaminophen, dipyronetreatment of acute migraine attack | Drug | – |
Primary outcome
Migraine treatment
Time frame: 2 hours
improvement of headache severity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders, run by Bnai Zion Medical Center at 1 site in Israel.
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 2 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 Sep 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 Israel. 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.
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 Jacob Genizi, MD (97248359442, jacob.genizi@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine treatment (time frame: 2 hours). 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 Sep 2021.