Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Intervention: Ketorolac, intranasal; Ketorolac, intravenous; Placebo, intravenous; Placebo, intranasal
Intervention description: 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.
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Intranasal; Ketorolac; Pediatric; Migraine; Headache

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present to the emergency department with a migraine headache as defined by the
             modified Irma criteria. The modified Irma criteria are as follows: Headache episodes
             of 1-168 hours (7 days) presenting with at least 3 of the following 6 criteria:
             moderate to severe episode of impaired daily activities; focal localization of
             headache; pulsatile description; nausea or vomiting or abdominal pain; photophobia or
             phonophobia or avoidance of light and noise; symptoms increasing with activity or
             resolving by rest.

          -  Headache severity of moderate to severe pain (i.e. at least 4/10 on the Faces Pain
             Scale - Revised)

          -  Requiring IV fluids and any IV medication (for example: ketorolac, metoclopramide,
             prochlorperazine, ondansetron) as part of their headache treatment, as per their
             treating attending physician

        Exclusion Criteria:

          -  Contraindication to receiving ketorolac

          -  Receipt of an NSAID within six hours of study drug administration

          -  Presence of an intranasal obstruction that cannot be readily cleared

          -  Inability to speak English or Spanish

          -  Unable to complete self-report measures of pain or questionnaires

          -  Critical illness

          -  Frequent use of drugs for headache (i.e. regular intake of analgesics for acute
             headaches on more than 10 days per month).