Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department
Keywords
Abstract
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.
Dates
| Last Verified: | 06/30/2019 |
| First Submitted: | 06/07/2018 |
| Estimated Enrollment Submitted: | 06/20/2018 |
| First Posted: | 07/02/2018 |
| Last Update Submitted: | 07/08/2019 |
| Last Update Posted: | 07/09/2019 |
| Actual Study Start Date: | 10/14/2018 |
| Estimated Primary Completion Date: | 11/30/2019 |
| Estimated Study Completion Date: | 11/30/2019 |
Condition or disease
Intervention/treatment
Drug: Lidocaine
Drug: Placebo
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Lidocaine Subjects will receive a one time dose of 20mg of 2% lidocaine (1 mL) via nasal mucosal atomizer | Drug: Lidocaine 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. |
| Placebo Comparator: Placebo Subjects will receive a one time dose of 1 mL of 0.9% sodium chloride solution via nasal mucosal atomizer. | Drug: Placebo 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. |
Eligibility Criteria
| Ages Eligible for Study | 10 Years To 10 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - 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: 1. non-occipital location of headache (frontal, frontotemporal, or unilateral) 2. pulsating or throbbing quality 3. aggravated by or causing avoidance of routine physical activity 4. nausea, vomiting, or both 5. photophobia and/or phonophobia (may be inferred from behavior) Exclusion Criteria: - 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 |
Outcome
Primary Outcome Measures
1. Change in Pain Score [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 Outcome Measures
1. The Number of Subjects with Improvement of Associated Symptoms [Prior to study drug administration at baseline and 20 minutes after study drug administration.]
2. The Number of Subjects Who Receive IV Pain Medications [1 hour]
3. The Number of Subjects with Rebound headache [1 hour.]
4. The Number of Subjects with Rebound headache after discharge [1 week]
5. The Number of Patients that Would Use Their Intranasal Medication the Next Time They Have a Migraine [1 hour]
