Background: Ibuprofen and Acetaminophen (APAP) are commonly used analgesics in the pediatric ED for acute traumatic/non-traumatic pain. However, the analgesic benefits of combination ibuprofen and acetaminophen in this specific setting do not exist, only in pediatric patients with postoperative pain. Our aim is to evaluate analgesic efficacy, safety and feasibility of combination therapy to potentially broaden its clinical application in the pediatric ED. We hypothesize that combination oral ibuprofen and APAP therapy is superior to either alone and is an excellent analgesic modality for controlling acute traumatic/non-traumatic pain in the pediatric ED.<
Methods: Prospective, randomized; double-blind trial evaluating ED patients aged 3-17 years with acute pain. Enrolled patients were randomized to three groups: Group 1: oral ibuprofen at 10mg/kg dose and placebo of equal volume; Group 2: oral APAP at 15 mg/kg dose and placebo of equal volume; and, Group 3: oral ibuprofen at 10 mg/kg dose and APAP at 15mg/kg dose. Analgesics are administered orally via pre-filled syringes of identical volume, color, and flavor. Pain scores are recorded on a standard Numeric Rating Scale (NRS) and Wong-Baker (FACES) Scale at baseline and 60 minutes. Primary outcome is the comparative reduction of pain via NRS/FACES pain scale at 60 minutes from administration of medication. Secondary outcomes include incidence and type of adverse events, antipyretic effects, and patients’ and parents’ satisfaction with achieved level of analgesia. Data are analyzed by intention-to-treat using frequency distributions, Chi-square test, and ANOVA. Power analysis indicates a need for total enrollment of at least 90 patients.
Results: To date we enrolled 59 patients (n=20, 20, and 19 respectively) and anticipate to enroll at least 90 by May 2018. The demographic characteristics are similar for all three groups (P>.05). The mean NRS pain scores at baseline were 5.25, 5.80, and 6.0 (P=0.463) and at 60 minutes the mean NRS pain scores were 2.30, 3.05, and 2.11 respectively. (P=0.396). Rescue analgesia were not requested or given to anyone, and there were no side effects in either group. <
Conclusion: The preliminary data indicates that combination of oral ibuprofen and APAP therapy is not superior to either drug alone for controlling acute traumatic/non-traumatic pain in the pediatric ED.