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.
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. Review. Erratum in: Headache. 2016 Apr;56(4):819.
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.
Maizels M, Geiger AM Intranasal lidocaine for migraine: a randomized trial and open-label follow-up. Headache. 1999 Sep;39(8):543-51. Erratum in: Headache 1999 Nov-Dec;39(10):764.
Maizels M Intranasal lidocaine to prevent headache following migraine aura. Headache. 1999 Jun;39(6):439-42.
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. Review.
Prensky AL, Sommer D Diagnosis and treatment of migraine in children. Neurology. 1979 Apr;29(4):506-10.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.