Resident Physician Nemours Children's Health, Florida Orlando, Florida, United States
Background: In procedures done in neonates and infants, such as MRI, LP, circumcision and IV placement, the use of sedatives is both necessary and preferred, with Dexmedetomidine offering a novel potential solution to this need. Dexmedetomidine administered intravenously is an effective form of sedation in pediatric patients, and has similar bioavailability when administered intranasally, based on previous studies. Intranasal dexmedetomidine has shown to be safe and effective compared to intravenous administration in adults, with limited literature regarding use in infants and neonates. Objective: This study aims to determine the safety and efficacy of intranasal dexmedetomidine for procedural sedation in neonates and infants. The objectives are: 1) Evaluate the safety of intranasal dexmedetomidine as demonstrated by its effect on vital signs in neonates and infants during procedures and 2) Evaluate the effectiveness of intranasal dexmedetomidine in neonates and infants as demonstrated by the use of dexmedetomidine as the sole sedating agent in a procedure. We hypothesize that intranasal dexmedetomidine is both safe and effective for procedural sedation in neonates and infants, which has not been previously demonstrated in the literature. Design/Methods: This is a cross sectional retrospective study based on an EMR review of patients at a freestanding children’s hospital who received intranasal dexmedetomidine from September 1 2013 to December 20 2022. Primary outcomes are change in blood pressure, heart rate and respiratory rate after drug administration. Secondary outcomes are drug dose administered, number of doses required and any use of alternate sedative. The primary outcome is to demonstrate the safety of intranasal dexmedetomidine in neonates and infants by describing the effect of administration on vital signs. The secondary outcome is to demonstrate efficacy of intranasal dexmedetomidine as a sedative in neonates and infants by describing the average dose, and need for any supplementary sedative. Data will be analyzed using descriptive analysis, including mean values of each continuous variable and frequencies for categorical variables . One-Sample t-test will be done for each primary outcome variable. Independent t-tests will be preformed for each primary outcome variable in relation to predictor variables, including age, weight, sex, comorbidities, race/ethnicity, insurance status, type of procedure. A Chi-Square will be done to assess independence of predictor variables, with significance at p < 0.05. Results: Pending
