Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department

NCT03576820 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: 2018-9278
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine

Keywords

pediatrics; intranasal lidocaine; migraine; headache; emergency department; pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Score

  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.

  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 Outcomes (5)

• 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

Study Arms (2)

Lidocaine

EXPERIMENTAL

Subjects will receive a one time dose of 20mg of 2% lidocaine (1 mL) via nasal mucosal atomizer

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

Subjects will receive a one time dose of 1 mL of 0.9% sodium chloride solution via nasal mucosal atomizer.

Drug: Placebo

Interventions

Lidocaine DRUG

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.

Also known as: 2% Lidocaine Hydrochloride Solution (20 mg/mL)

Lidocaine

Placebo DRUG

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.

Also known as: 0.9% sodium chloride solution

Placebo

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Related Publications (12)

• 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: 29201961 BACKGROUND

• 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: 27739142 BACKGROUND

• 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: 21669320 BACKGROUND

• 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: 21030365 BACKGROUND

• 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: 11279969 BACKGROUND

• 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: 11279923 BACKGROUND

• 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: 26486800 BACKGROUND

• 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: 20530076 BACKGROUND

• 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: 29532087 BACKGROUND

• 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: 14747817 BACKGROUND

• 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: 571549 BACKGROUND

• 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.

  PMID: 7737865 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Headache; Emergencies; Pain

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Katherine Chou, MD

  New York City Health and Hospitals Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wende Gelb, MD

CONTACT

718-918-5312; gelbw@nychhc.org

Katherine Chou, MD

CONTACT

718-918-5312; katherine.chou@nychhc.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The medication and placebo doses will be prepared in the pharmacy at the study site and provided to the investigators in deidentified syringes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: July 3, 2018
• Study Start: October 15, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)