Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      Ketorolac is an evidence-based, first-line acute migraine therapy that is commonly used in
      the pediatric population; however, it is typically administered by the intravenous (IV) or
      intramuscular (IM) routes, both of which require a painful and distressing needle stick to
      administer.

      The intranasal (IN) route is a painless and effective way of administering analgesics,
      including ketorolac: IN ketorolac has been shown to be an effective analgesic in adults for
      painful conditions, including acute migraine headaches. However, IN ketorolac has been
      understudied in children, and it is not known how effective it is compared to IV ketorolac,
      which is currently the most common way of administering ketorolac to children. If IN
      ketorolac is shown to be no less effective than IV ketorolac, IN ketorolac may be a viable
      and painless alternative to effectively treat acute migraine headaches in children.

      Therefore, our primary aim is to demonstrate that IN ketorolac is non-inferior to IV
      ketorolac for reducing pain in children with acute migraine headaches.
    

Detailed description: 
      Primary Aim: Determine whether intranasal (IN) ketorolac is non-inferior to intravenous (IV)
      ketorolac for reducing pain in children with acute migraine headaches. We hypothesize that IN
      ketorolac is non-inferior to IV ketorolac in reducing acute migraine headache pain by a
      minimum clinically significant difference within 60 minutes of administration.

      Secondary Aim: Determine whether there is a difference in time to achieve a clinically
      significant reduction in pain after receiving IN ketorolac compared to IV ketorolac. We
      hypothesize that there is no difference between IN ketorolac and IV ketorolac in the time it
      takes to achieve a clinically significant reduction in pain.

      We will conduct a prospective, double-blinded, randomized, non-inferiority, parallel 1:1
      clinical trial of eligible children in a single urban pediatric ED. We will block randomize
      patients to receive either 1 mg/kg IN ketorolac and an IV placebo (study group A), or 0.5
      mg/kg IV ketorolac and an IN placebo (study group B).

      We will assess the patient's pain at baseline, and then at 10 minutes, 30 minutes and 60
      minutes after administration of the study drug. The patient will then be assessed at 2 hours
      and 24 hours after study drug administration for outcomes related to efficacy, function, and
      safety.
    

Intervention name(s): Ketorolac, intranasal; Ketorolac, intravenous; Placebo, intravenous; Placebo, intranasal
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route.; Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route.; Placebo of equal volume to IV ketorolac, to be administered by intravenous route.; Placebo of equal volume to IN ketorolac, to be administered by intranasal route.
Other intervention name(s): Toradol; Toradol
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intranasal; Ketorolac; Pediatric; Migraine; Headache