TOP 18 - Efficacy of Nasal Migraine Cocktail used in Pediatric Emergency Department: A Clinical Trial

Publication Number: 4720.TOP 18

Sophia Rifkin, St. Louis Children's Hospital, St. Louis, MO, United States; Carlee Lenehan, Primary Children's Hospital, Park City, UT, UT, United States; Stacey L.. House, Washington University in St. Louis School of Medicine, St. Louis, MO, United States; Fahd A. Ahmad, Washington University in St. Louis, St. Louis, MO, United States; Saumel Ahmadi, Washington University in St Louis, St Louis, MO, United States; Kavya A. John, Washington University School of Medicine, St. Louis, MO, United States; George Hoganson, Washington University in St. Louis School of Medicine, St. Louis, MO, United States; Kimberly Quayle, Washington University in St. Louis School of Medicine, St. Louis, MO, United States

Background: Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) frequently used as a treatment for migraine headaches in both adult and pediatric patients. The intravenous (IV) form of Ketorolac is often used as a single medication or in combination with other medications in the emergency department (ED). Previous studies have demonstrated the efficacy of ketorolac for migraine treatment, however the placement of an IV can cause significant distress in pediatric patients. Previously, intranasal ketorolac has been shown to be an effective alternative to IV Ketorolac, and however the use of Ketorolac in the ED as part of migraine cocktail has not been studied. This study examines the effectiveness of this needle-free and easier to administer form of ketorolac (intranasal) as part of a migraine cocktail.

Objective: To determine whether intranasal ketorolac is non-inferior to intravenous ketorolac when used with adjuncts for reducing pain in children with migraine headaches.

Design/Methods: We conducted a prospective, double-blinded, randomized, non-inferiority trial at an urban pediatric emergency department. The study included children aged 6-17.9 years with moderate to severe acute migraine pain (≥4/10 on the Faces Pain Scale-Revised (FPS-R)) requiring IV medication. Exclusion criteria included allergies or other contraindications to ketorolac, intranasal obstruction, inability to self-report pain, and concurrent conditions that could affect study outcomes.

Participants were randomized to receive either intranasal (IN) ketorolac (1 mg/kg) with oral prochlorperazine (0.1mg/kg, max 10mg) and diphenhydramine (1mg/kg, max 50mg) (Group A) or IV ketorolac (0.5 mg/kg, max 30 mg) with the same oral adjuncts (Group B).

We assessed patient pain using FPS-R at baseline, at 10, 30, and 60 minutes, as well as 2 and 24 hours post-administration, with follow-up extended to 72 hours if the 24-hour assessment was missed. Our primary outcome was the pain assessment 60 minutes after receiving study medication. Secondary outcomes include time to onset of clinically meaningful decrease in pain; ancillary emergency department outcomes (e.g. receipt of rescue medications, headache relief, headache freedom, percentage improvement); 24- hour follow-up outcomes; and adverse events.