Clinical trial NCT03576820: Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department
Official title: Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Migraine
Keywords: pediatrics
intranasal lidocaine
migraine
headache
emergency department
pain
Lead sponsor: New York City Health and Hospitals Corporation
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
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.
Secondary outcomes:
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.
measure: The Number of Subjects Who Receive IV Pain Medications
timeFrame: 1 hour
measure: The Number of Subjects with Rebound headache
timeFrame: 1 hour.
measure: The Number of Subjects with Rebound headache after discharge
timeFrame: 1 week
measure: The Number of Patients that Would Use Their Intranasal Medication the Next Time They Have a Migraine
timeFrame: 1 hour
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
Study officials:
affiliation: New York City Health and Hospitals Corporation
name: Katherine Chou, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.