Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Pain Score
研究概览
简要总结
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.
详细描述
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.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The medication and placebo doses will be prepared in the pharmacy at the study site and provided to the investigators in deidentified syringes.
入排标准
- 年龄范围
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •aggravated by or causing avoidance of routine physical activity
- •nausea, vomiting, or both
- •photophobia and/or phonophobia (may be inferred from behavior)
排除标准
- •unstable vital signs
- •pregnancy
- •lactating
- •altered mental status
- •developmental delay
- •intractable vomiting
- •first-time headache
- •history of cardiac arrythmia
- •previous adverse reaction or allergy to lidocaine
- •non-English speaking
研究组 & 干预措施
Lidocaine
Subjects will receive a one time dose of 20mg of 2% lidocaine (1 mL) via nasal mucosal atomizer
干预措施: Lidocaine (Drug)
Placebo
Subjects will receive a one time dose of 1 mL of 0.9% sodium chloride solution via nasal mucosal atomizer.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Pain Score
时间窗: 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.
次要结局
- The Number of Subjects with Improvement of Associated Symptoms(Prior to study drug administration at baseline and 20 minutes after study drug administration.)
- The Number of Subjects Who Receive IV Pain Medications(1 hour)
- The Number of Subjects with Rebound headache(1 hour.)
- The Number of Subjects with Rebound headache after discharge(1 week)
- The Number of Patients that Would Use Their Intranasal Medication the Next Time They Have a Migraine(1 hour)