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Patients, parents, treating physicians, and outcome assessors were blinded to group allocation. The primary outcome, a tolerability measure, was the frequency of cumulative side effects and adverse events within 60 minutes of drug administration. The secondary outcomes included the difference in mean pain score reduction at 20 minutes, the proportion of patients achieving a clinically significant reduction in pain in 20 minutes, total dose of opioid pain medication in morphine equivalents\/kg\/hour (excluding study drug) required during the emergency department (<jats:styled-content style=\"fixed-case\">ED<\/jats:styled-content>) stay, and the feasibility of enrolling children presenting to the <jats:styled-content style=\"fixed-case\">ED<\/jats:styled-content> in acute pain into a randomized trial conducted under U.S. regulations. All patients were monitored until 6 hours after their last dose of study drug or until admission to the hospital ward or operating room.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 629 patients screened, 87 received the study drug and 82 had complete data for the primary outcome (41 patients in each group). The median (interquartile range) age was 8 (6\u201311) years and 62% were male. Baseline pain scores were similar among patients randomized to receive ketamine (73\u00a0\u00b1\u00a026) and fentanyl (69\u00a0\u00b1\u00a026; mean difference [95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>]\u00a0= 4 [\u20137 to 15]). The cumulative number of side effects was 2.2 times higher in the ketamine group, but there were no serious adverse events and no patients in either group required intervention. The most common side effects of ketamine were bad taste in the mouth (37; 90.2%), dizziness (30;\u00a073.2%), and sleepiness (19; 46.3%). The most common side effects of fentanyl were sleepiness (15; 36.6%), bad taste in the mouth (9; 22%), and itchy nose (9; 22%). No patients experienced respiratory side effects. At 20 minutes, the mean pain scale score reduction was 44\u00a0\u00b1\u00a036 for ketamine and 35\u00a0\u00b1\u00a029 for fentanyl (mean difference\u00a0= 9 [95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>\u00a0= \u20134 to 23]). Procedural sedation with ketamine occurred in 28 ketamine patients (65%) and 25 fentanyl patients (57%) prior to completing the study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Intranasal ketamine was associated with more minor side effects than intranasal fentanyl. Pain relief at 20 minutes was similar between groups. Our data support the feasibility of a larger, noninferiority trial to more rigorously evaluate the safety, efficacy, and potential opioid\u2010sparing benefits of intranasal ketamine analgesia for children with acute pain.<\/jats:p><\/jats:sec>","DOI":"10.1111\/acem.13313","type":"journal-article","created":{"date-parts":[[2017,9,19]],"date-time":"2017-09-19T12:42:38Z","timestamp":1505824958000},"page":"1430-1440","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":59,"title":["Randomized Controlled Feasibility Trial of Intranasal Ketamine Compared to Intranasal Fentanyl for Analgesia in Children with Suspected Extremity Fractures"],"prefix":"10.1111","volume":"24","author":[{"given":"Stacy L.","family":"Reynolds","sequence":"first","affiliation":[{"name":"Department of Emergency Medicine Carolinas Medical Center"},{"name":"Levine Children's Hospital Emergency 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