Occipital Nerve Blocks for Acute Treatment of Pediatric Migraine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS)
研究概览
简要总结
Migraine affects 10-28% of children and adolescents and yet 20-30% of patients are ineffectively treated with current oral and nasal options. Peripheral nerve blocks (PNBs), injections of local anesthetics over branches of the occipital and/or trigeminal nerves, have been associated with possible benefit for pediatric headaches in case series, and may be useful for both acute and preventive treatment of migraine for children who fail less invasive treatments. In fact, 80% of pediatric headache specialists reported using peripheral nerve blocks and carry low risk of serious side effects; however, peripheral nerve blocks have never been tested, formally, in a randomized pediatric trial.
By applying a novel design that utilizes lidocaine cream as a run-in step, investigators intend to test the efficacy of the most commonly used peripheral nerve block, the greater occipital nerve (GON) block, as an acute treatment for pediatric migraine and determine whether lidocaine cream leads to successful blinding of the injection.
The GON block is expected to prove effective in decreasing the pain of migraine, with lidocaine being superior to saline and lidocaine cream maintaining blinding.
详细描述
There are two substantial hurdles that must be overcome in designing a trial to test the efficacy of PNBs: high placebo response rate and possible unblinding. In order to test the efficacy of this commonly used treatment for children and adolescents with difficult-to-treat headache, we need utilize a trial design which will address the high placebo response rate and the potential lack of blinding.
About 194 children, recruited over a 3.5 year period at Children's Hospital of Philadelphia, will take part in this study. Participation will last about one month and involve one in-person study visit, and then completion of headache-related surveys, at home, for 28 days. Lidocaine cream lead-in will be used open-label for all subjects followed by double-blind randomized injections of active treatment (lidocaine) versus comparator (saline) in subjects who continue to have significant headache.
To accomplish our secondary objectives, we will examine how expectation is affected by perceived treatment, and how expectations, measured in patients, parents, and providers, influence outcomes in pediatric and adolescent acute migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 7 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children / Adolescents:
- •Males or females, ages 7 - 21, of any gender, race, or ethnicity
- •Diagnosis of episodic or chronic migraine with acute headache flare lasting up to 3 months unresponsive to acute medications. Patients who report that acute medications were not used during this headache flare because those medications have been ineffective for several prior headache flares will be included
- •Informed parental consent and subject assent
- •Girls, who have reached menarche, must have a negative urine or serum pregnancy test
- •Weight > 25kg
- •Parents or guardians of children enrolled, who speak either English or Spanish, and provide parental/guardian permission (informed consent) for their own participation
- •Subject (child) assent
排除标准
- •Children / Adolescents:
- •Previous nerve block less than 3 months ago or more than 2 previous nerve blocks
- •Allergy to local anesthetics
- •Skull defect or break in the skin at the planned site of cream application or GON injection
- •Any investigational drug use within 30 days prior to enrollment, or 90 days prior to enrollment for medications targeted at Calcitonin Gene-Related Peptide
- •Pregnant or lactating females
- •Parents/guardians or subjects who, in the opinion of the Investigator, may be non- compliant with study schedules or procedures
- •Significant adverse event with prior injection or procedure
- •New abnormalities on physical or neurological examination
- •Newly reported red flags in headache history which prompt investigation for secondary headache
- •Non-English and Non-Spanish speaking
- •Non-English speaking with no Spanish interpreter available
- •Parents or guardians of children enrolled, who do not speak either English or Spanish
- •Parental/guardian permission and/or subject (child) assent has been declined
- •Parents or guardians, who in the opinion of the investigator, may be non-compliant or unable to complete the questionnaires
研究组 & 干预措施
Greater Occipital Nerve (GON) Block with Lidocaine
Subjects randomized to this arm receive 2 mL injection of lidocaine 2% over the right and left greater occipital nerve at the baseline study visit.
All subjects then complete daily headache-related questions through a Headache Diary and other assessments for 28 days.
干预措施: Lidocaine 4% Topical Application Cream [LMX 4] (Drug)
Greater Occipital Nerve (GON) Block with Lidocaine
Subjects randomized to this arm receive 2 mL injection of lidocaine 2% over the right and left greater occipital nerve at the baseline study visit.
All subjects then complete daily headache-related questions through a Headache Diary and other assessments for 28 days.
干预措施: Lidocaine Hydrochloride 2 mg/mL Injectable Solution (Drug)
Greater Occipital Nerve (GON) Block with Saline
Subjects randomized to this arm receive 2 mL injection of preservative-free normal saline over the right and left greater occipital nerve at the baseline study visit.
All subjects then complete daily headache-related questions through a Headache Diary and other assessments for 28 days.
干预措施: Lidocaine 4% Topical Application Cream [LMX 4] (Drug)
Greater Occipital Nerve (GON) Block with Saline
Subjects randomized to this arm receive 2 mL injection of preservative-free normal saline over the right and left greater occipital nerve at the baseline study visit.
All subjects then complete daily headache-related questions through a Headache Diary and other assessments for 28 days.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS)
时间窗: Pre-injection (*Baseline*) and 30 minutes Post-injection
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Numeric Rating Scale (NRS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. NRS scale is a 0 to 10 scale, with 0 meaning no pain and 10 meaning "the worse pain imaginable". A mean change of 2-points has been shown to be clinically relevant.
Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS)
时间窗: Pre-injection and 30 minutes Post-injection
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning "the worse pain imaginable".
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Sex
时间窗: Pre-injection (*Baseline*) and 30 minutes Post-injection
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Numeric Rating Scale (NRS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By sex. NRS scale is a 0 to 10 scale, with 0 meaning no pain and 10 meaning "the worse pain imaginable". A mean change of 2-points has been shown to be clinically relevant.
Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Sex
时间窗: Pre-injection and 30 minutes Post-injection
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By sex. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning "the worse pain imaginable".
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Ethnicity
时间窗: Pre-injection (*Baseline*) and 30 minutes Post-injection
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Numeric Rating Scale (NRS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By ethnicity. NRS scale is a 0 to 10 scale, with 0 meaning no pain and 10 meaning "the worse pain imaginable". A mean change of 2-points has been shown to be clinically relevant.
Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Ethnicity
时间窗: Pre-injection and 30 minutes Post-injection
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By ethnicity. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning "the worse pain imaginable".
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Race
时间窗: Pre-injection (*Baseline*) and 30 minutes Post-injection
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Numeric Rating Scale (NRS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By race. NRS scale is a 0 to 10 scale, with 0 meaning no pain and 10 meaning "the worse pain imaginable". A mean change of 2-points has been shown to be clinically relevant.
Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Race
时间窗: score on a scale
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By race. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning "the worse pain imaginable".
次要结局
- Change From Baseline Disability to Day 7(Baseline and Day 7)
- Percentage of Subjects With Sustained Pain Relief(24 hours Post-injection)
- Percentage of Subjects With Pain Freedom(30 minutes Post-injection)
- Percentage of Subjects With Sustained Pain Freedom(24 hours Post-injection)
- Percentage of Subjects With Freedom From All Symptoms of Migraine(24 hours Post-injection)
- Change From Baseline Disability to Week 4(Baseline and Week 4)
- Change From Baseline Disability(Baseline and Week 4)
- Percentage of Subjects With Pain Relief or Headache Response(30 minutes Post-injection)