278 Intranasal Ketamine for Procedural Sedation in Children: A Randomized Controlled Pilot Study

Abstract

The pain of intravenous (IV) insertion is rated by children as second only to disease-related pain. Procedural sedation and analgesia (PSA) is a common indication for IV insertion in the emergency department (ED). Ketamine is the most frequently used agent for PSA in children. Intranasal ketamine (INK) has shown effectiveness for PSA in a limited number of painful procedures (IV insertion, gastric aspiration, and laceration repair) but no studies have explored INK for fracture reduction in children. Our objective was to evaluate the feasibility of INK for PSA in children who sustained a fracture requiring a closed reduction. This was a randomized, blinded, controlled, trial comparing the effectiveness of INK versus intravenous ketamine (IVK). We included children 4-17 years, < 40 kg with a non-shortened distal forearm fracture requiring PSA for closed reduction. Participants were randomized using a double-dummy approach to receive single dose (i) INK 8 mg/kg (maximum 320 mg) + 0.9% IV normal saline OR (ii) IVK 1 mg/kg (maximum of 40 mg) + IN 0.9% normal saline. The primary outcome was the proportion of participants with adequate sedation during closed reduction as defined by a University of Michigan Sedation Scale (UMSS) score of > 3 of 4. Secondary outcomes included need for additional IV sedation, adverse effects, time to sedation defined as a UMSS score of > 3 of 4, and length of stay. Fifteen participants were consecutively recruited from March 1, 2016 to Feb 1, 2017. Seven children (3 females) received INK and the mean (SD) age was 6.6 (3.1) years. Eight children (3 females) received IVK and the mean (SD) age was 5.9 (2) years. Adequate sedation was achieved by 4/7 (57.1%) versus 7/8 (87.5%) participants in the INK and IVK groups, respectively (p = 0.28). The median (IQR) time to sedation was 10 (11.3) versus 5 (0) minutes in the INK and IVK groups, respectively (p = 0.23). Additional IVK was required by 5/7 (71.4%) versus 2/8 (25%) of participants in the INK and IVK groups, respectively (p = 0.13). Adverse effects consisting of nausea, vomiting, or dizziness were seen in 4/7 (57.1) versus 2/8 (25%) of participants in the INK and IVK groups, respectively (p = 0.32). No participants experienced emergence agitation and there were no serious adverse events. The median (IQR) length of stay in the INK and IVK groups was 364 (153) versus 290 (113) minutes, respectively (p = 0.13). The adequacy of sedation for INK 8 mg/kg is inconsistent for closed reduction of distal forearm fractures in children. Greater sedative efficacy may be achieved with a higher INK dose (9-10 mg/kg), consistent with demonstrated effectiveness in other studies of PSA in children undergoing painful procedures.