ABSTRACT
BACKGROUND: Acute gastroenteritis is an important reason for emergency department (ED) consultation in children. Ondansetron is reported to be effective in reducing vomiting in children with gastroenteritis, leading to less intravenous rehydration and hospital admission. OBJECTIVE(S): The aim of this study was to assess the effectiveness of triage nurse-initiated administration of ondansetron for children with suspected gastroenteritis in the paediatric ED to reduce the number of patients requiring observation following the first physician assessment. DESIGN/METHODS: This was a randomized controlled trial performed in a tertiary care paediatric ED. All children 6 months to 17 years old who presented to the ED with at least four episodes of non-billous, non-bloody vomiting in the previous 24 hours and the last vomiting occurring within the previous 2h were eligible. The intervention consisted of administration of a liquid formulation of an adapted to weight dose of ondansetron at triage compared to a color- and taste-matched placebo. The primary outcome was the number of patients requiring observation after the first physician's evaluation. Secondary outcomes were the number of episodes of vomiting after receiving the intervention, length of stay in the ED, comfort, and the proportion of children who returned for a medical visit within 48 hours. A sample size of 248 participants was initially identified to have a power of 90% to find a 20% difference in the proportion of children needing observation following physician evaluation. RESULT(S): Because of multiple external factors, including the COVID-19 pandemic, recruitment was stopped before the expected sample size was reached. A total of 91 patients were included and randomized to receive ondansetron (n= 44) or a placebo (n=47) just after triage. The baseline characteristics of the participants was similar between the two groups. A total of 40 (45%) participants were discharged immediately after the first evaluation by the treating physician. This was similar for both groups 44% vs. 45%;(95% CI for the difference -20 to 19%). There was no difference between the two groups for the total length of stay (median 232 vs. 227 minutes;p= 0.677) and for the length of stay after being seen by the physician (72 vs. 68 minutes;p=0.821). There was no statistical difference between the two groups in the number of vomiting episodes (difference of 15%;95% CI -2, 31), and proportion of participants needing a rescue medication (difference: 19%;95%CI:-0.6 to 36%) or an intravenous rehydration (difference: 8;95%CI:-6, 22). CONCLUSION(S): This study failed to demonstrate any benefit in using ondansetron at triage for children with presumed gastroenteritis.
ABSTRACT
BACKGROUND: Nasopharyngeal (NP) swabs have been recommended to detect SARS-CoV-2 since the beginning of the COVID-19 pandemic, but are reported to be at least moderately painful. OBJECTIVE(S): To evaluate the efficacy of intranasal vaporized lidocaine compared to a sham treatment in reducing pain in children undergoing a NP swab in the Emergency Department (ED). DESIGN/METHODS: A randomized double-blinded clinical trial was conducted in a pediatric ED. Both participants and the researcher evaluating the primary outcome were blinded. Children 6 to 17 years old requiring a NP swab were eligible. Participants were randomly allocated to receive intranasal lidocaine or a sham treatment prior to their NP swab. The primary outcome measure was pain during the swab as assessed by the visual analog scale. Secondary outcome measures were pain using the verbal numeric rating scale, fear using the children fear scale, and side effects of the intervention. RESULT(S): Eighty-eight participants were enrolled: 45 to the lidocaine group and 43 to the control group. The mean visual analog scale scores for pain were 46 mm in the lidocaine group and 53 mm in the control group (mean difference 7 mm;95%CI -5 to 19 mm). The numeric rating scale and children fear scale were not statistically different between groups. No serious adverse events were observed. Fear prior to the test and younger age were associated with higher pain scores. CONCLUSION(S): Intranasal lidocaine administered prior to NP swabs in the ED did not lower pain scores for school-aged children and youth.