IMPORTANCE Timely analgesia is critical for children with injuries presenting to the emergency department, yet pain control efforts are often inadequate. Intranasal administration of pain medications provides rapid analgesia with minimal discomfort. Opioids are historically used for significant pain from traumatic injuries but have concerning adverse effects. Intranasal ketamine may provide an effective alternative. OBJECTIVE To determine whether intranasal ketamine is noninferior to intranasal fentanyl for pain reduction in children presenting with acute extremity injuries. DESIGN, SETTING, AND PARTICIPANTS The Pain Reduction With Intranasal Medications for Extremity Injuries (PRIME) trial was a double-blind, randomized, active-control, noninferiority trial in a pediatric, tertiary, level 1 trauma center. Participants were children aged 8 to 17 years presenting to the emergency department with moderate to severe pain due to traumatic limb injuries between March 2016 and February 2017. Analyses were intention to treat and began in May 2017. INTERVENTIONS Intranasal ketamine (1.5 mg/kg) or intranasal fentanyl (2 μg/kg). MAIN OUTCOMES AND MEASURES The primary outcome was reduction in visual analog scale pain score 30 minutes after intervention. The noninferiority margin for this outcome was 10. RESULTS Of 90 children enrolled, 45 (50%) were allocated to ketamine (mean [SD] age, 11.8 [2.6] years; 26 boys [59%]) and 45 (50%) to fentanyl (mean [SD] age, 12.2 [2.3] years; 31 boys [74%]). Thirty minutes after medication, the mean visual analog scale reduction was 30.6 mm (95% CI, 25.4-35.8) for ketamine and 31.9 mm (95% CI, 26.6-37.2) for fentanyl. Ketamine was noninferior to fentanyl for pain reduction based on a 1-sided test of group difference less than the noninferiority margin, as the CIs crossed 0 but did not cross the prespecified noninferiority margin (difference in mean pain reduction between groups, 1.3; 90% CI, −6.2 to 8.7). The risk of adverse events was higher in the ketamine group (relative risk, 2.5; 95% CI, 1.5-4.0), but all events were minor and transient. Rescue analgesia was similar between groups (relative risk, 0.89; 95% CI, 0.5-1.6). CONCLUSIONS AND RELEVANCE Ketamine provides effective analgesia that is noninferior to fentanyl, although participants who received ketamine had an increase in adverse events that were minor and transient. Intranasal ketamine may be an appropriate alternative to intranasal fentanyl for pain associated with acute extremity injuries. Ketamine should be considered for pediatric pain management in the emergency setting, especially when opioids are associated with increased risk.
Study objective The impact of public health interventions during the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) pandemic on critical illness in children has not been studied. We seek to determine the impact of SARS‐CoV‐2 related public health interventions on emergency healthcare utilization and frequency of critical illness in children. Methods This was an interrupted time series analysis conducted at a single tertiary pediatric emergency department (PED). All patients evaluated by a provider from December 31 through May 14 of 6 consecutive years (2015‐2020) were included. Total patient visits (ED and urgent care), shock trauma suite (STS) volume, and measures of critical illness were compared between the SARS‐CoV‐2 period (December 31, 2019 to May 14, 2020) and the same period for the previous 5 years combined. A segmented regression model was used to explore differences in the 3 outcomes between the study and control period. Results Total visits, STS volume, and volume of critical illness were all significantly lower during the SARS‐CoV‐2 period. During the height of public health interventions, per day there were 151 fewer total visits and 7 fewer patients evaluated in the STS. The odds of having a 24‐hour period without a single critical patient were >5 times higher. Trends appeared to start before the statewide shelter‐in‐place order and lasted for at least 8 weeks. Conclusions In a metropolitan area without significant SARS‐CoV‐2 seeding, the pandemic was associated with a marked reduction in PED visits for critical pediatric illness.
With our improvement methodology, we successfully increased guideline-adherent evaluation for patients with provider concern for NAT. Education and electronic support at the point of care were key drivers for initial implementation.
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