Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT03576820
Status:
UNKNOWN
Last Update Posted:
2021-01-05
First Post:
2018-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The medication and placebo doses will be prepared in the pharmacy at the study site and provided to the investigators in deidentified syringes.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-31', 'studyFirstSubmitDate': '2018-06-08', 'studyFirstSubmitQcDate': '2018-06-21', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Score', 'timeFrame': '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.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The Number of Subjects with Improvement of Associated Symptoms', 'timeFrame': 'Prior to study drug administration at baseline and 20 minutes after study drug administration.', 'description': 'The presence or absence of nausea, vomiting, photophobia, phonophobia, aura, and avoidance of daily activities will be asked to each subject at baseline. At 20 minutes each subject will be asked to respond "yes" or "no" if each associated symptom has subjectively improved.'}, {'measure': 'The Number of Subjects Who Receive IV Pain Medications', 'timeFrame': '1 hour', 'description': "All subjects will be ordered to receive IV metoclopramide. If a subject's pain significantly improved after intranasal drug administration and before IV metoclopramide administration, then metoclopramide will be held, as per discretion of the treating physician. At the end of the study the treating physician will document on the data collection sheet if the subject received IV pain medications."}, {'measure': 'The Number of Subjects with Rebound headache', 'timeFrame': '1 hour.', 'description': 'Each subject will be asked to respond "yes" or "no" if their headache returned at 1 hour post study drug administration.'}, {'measure': 'The Number of Subjects with Rebound headache after discharge', 'timeFrame': '1 week', 'description': 'Each subject will be called within 1 week of discharge and asked to respond "yes" or "no" if they had rebound headache.'}, {'measure': 'The Number of Patients that Would Use Their Intranasal Medication the Next Time They Have a Migraine', 'timeFrame': '1 hour', 'description': 'At the end of the study all subjects will be asked if they would use their intranasal medication the next time they have a migraine'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatrics', 'intranasal lidocaine', 'migraine', 'headache', 'emergency department', 'pain'], 'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '29201961', 'type': 'BACKGROUND', 'citation': 'Barzegari H, Motamed H, Ziapour B, Hajimohammadi M, Kadkhodazadeh M. Intranasal Lidocaine for Primary Headache Management in Emergency Department; a Clinical Trial. Emerg (Tehran). 2017;5(1):e79. Epub 2017 Sep 16.'}, {'pmid': '27739142', 'type': 'BACKGROUND', 'citation': 'Smith D, Cheek H, Denson B, Pruitt CM. Lidocaine Pretreatment Reduces the Discomfort of Intranasal Midazolam Administration: A Randomized, Double-blind, Placebo-controlled Trial. Acad Emerg Med. 2017 Feb;24(2):161-167. doi: 10.1111/acem.13115. Epub 2017 Jan 30.'}, {'pmid': '21669320', 'type': 'BACKGROUND', 'citation': 'Yaeger J. Adding intranasal lidocaine to midazolam may benefit children undergoing procedural sedation. J Pediatr. 2011 Jul;159(1):166. doi: 10.1016/j.jpeds.2011.05.010. No abstract available.'}, {'pmid': '21030365', 'type': 'BACKGROUND', 'citation': 'Chiaretti A, Barone G, Rigante D, Ruggiero A, Pierri F, Barbi E, Barone G, Riccardi R. Intranasal lidocaine and midazolam for procedural sedation in children. Arch Dis Child. 2011 Feb;96(2):160-3. doi: 10.1136/adc.2010.188433. Epub 2010 Oct 27.'}, {'pmid': '11279969', 'type': 'BACKGROUND', 'citation': 'Maizels M, Geiger AM. Intranasal lidocaine for migraine: a randomized trial and open-label follow-up. Headache. 1999 Sep;39(8):543-51. doi: 10.1046/j.1526-4610.1999.3908543.x.'}, {'pmid': '11279923', 'type': 'BACKGROUND', 'citation': 'Maizels M. Intranasal lidocaine to prevent headache following migraine aura. Headache. 1999 Jun;39(6):439-42. doi: 10.1046/j.1526-4610.1999.3906439.x.'}, {'pmid': '26486800', 'type': 'BACKGROUND', 'citation': 'Kabbouche M. Management of Pediatric Migraine Headache in the Emergency Room and Infusion Center. Headache. 2015 Nov-Dec;55(10):1365-70. doi: 10.1111/head.12694. Epub 2015 Oct 21.'}, {'pmid': '20530076', 'type': 'BACKGROUND', 'citation': 'Richer LP, Laycock K, Millar K, Fitzpatrick E, Khangura S, Bhatt M, Guimont C, Neto G, Noseworthy S, Siemens R, Gouin S, Rowe BH; Pediatric Emergency Research Canada Emergency Department Migraine Group. Treatment of children with migraine in emergency departments: national practice variation study. Pediatrics. 2010 Jul;126(1):e150-5. doi: 10.1542/peds.2009-2337. Epub 2010 Jun 7.'}, {'pmid': '29532087', 'type': 'BACKGROUND', 'citation': 'Patterson-Gentile C, Szperka CL. The Changing Landscape of Pediatric Migraine Therapy: A Review. JAMA Neurol. 2018 Jul 1;75(7):881-887. doi: 10.1001/jamaneurol.2018.0046.'}, {'pmid': '14747817', 'type': 'BACKGROUND', 'citation': 'Brousseau DC, Duffy SJ, Anderson AC, Linakis JG. Treatment of pediatric migraine headaches: a randomized, double-blind trial of prochlorperazine versus ketorolac. Ann Emerg Med. 2004 Feb;43(2):256-62. doi: 10.1016/s0196-0644(03)00716-9.'}, {'pmid': '571549', 'type': 'BACKGROUND', 'citation': 'Prensky AL, Sommer D. Diagnosis and treatment of migraine in children. Neurology. 1979 Apr;29(4):506-10. doi: 10.1212/wnl.29.4.506.'}, {'pmid': '7737865', 'type': 'BACKGROUND', 'citation': 'Kudrow L, Kudrow DB, Sandweiss JH. Rapid and sustained relief of migraine attacks with intranasal lidocaine: preliminary findings. Headache. 1995 Feb;35(2):79-82. doi: 10.1111/j.1526-4610.1995.hed3502079.x.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will be receiving IV metoclopramide because their migraine is refractory to oral analgesics, as determined by the treating physician.\n* Moderate to severe headache with NRS score greater than or equal to 6\n* Headache lasting between 2-72 hours\n* Two of the following:\n\n 1. non-occipital location of headache (frontal, frontotemporal, or unilateral)\n 2. pulsating or throbbing quality\n 3. aggravated by or causing avoidance of routine physical activity\n 4. nausea, vomiting, or both\n 5. photophobia and/or phonophobia (may be inferred from behavior)\n\nExclusion Criteria:\n\n* unstable vital signs\n* pregnancy\n* lactating\n* altered mental status\n* developmental delay\n* intractable vomiting\n* first-time headache\n* history of cardiac arrythmia\n* previous adverse reaction or allergy to lidocaine\n* non-English speaking'}, 'identificationModule': {'nctId': 'NCT03576820', 'briefTitle': 'Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'New York City Health and Hospitals Corporation'}, 'officialTitle': 'Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department', 'orgStudyIdInfo': {'id': '2018-9278'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine', 'description': 'Subjects will receive a one time dose of 20mg of 2% lidocaine (1 mL) via nasal mucosal atomizer', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects will receive a one time dose of 1 mL of 0.9% sodium chloride solution via nasal mucosal atomizer.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['2% Lidocaine Hydrochloride Solution (20 mg/mL)'], 'description': '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.', 'armGroupLabels': ['Lidocaine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['0.9% sodium chloride solution'], 'description': '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.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wende Gelb, MD', 'role': 'CONTACT', 'email': 'gelbw@nychhc.org', 'phone': '718-918-5312'}, {'name': 'Katherine Chou, MD', 'role': 'CONTACT', 'email': 'katherine.chou@nychhc.org', 'phone': '718-918-5312'}, {'name': 'Katherine Chou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wende Gelb, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Jacobi Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'centralContacts': [{'name': 'Wende Gelb, MD', 'role': 'CONTACT', 'email': 'gelbw@nychhc.org', 'phone': '718-918-5312'}, {'name': 'Katherine Chou, MD', 'role': 'CONTACT', 'email': 'katherine.chou@nychhc.org', 'phone': '718-918-5312'}], 'overallOfficials': [{'name': 'Katherine Chou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York City Health and Hospitals Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York City Health and Hospitals Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}