RESUMEN
BACKGROUND AND AIMS: Intranasal midazolam (INM) sedation for children has been associated with side effects. This prospective, double-blind, placebo-controlled trial assessed whether the addition of lidocaine to INM (INM+L) affected efficacy or discharge time among pediatric patients undergoing elective bilateral myringotomy and tube placement (BMT). METHODS: This trial enrolled children aged between 18 months to seven years undergoing BMT, physical status class 1 or 2, in a single academic medical center. Interventions were placebo (intranasal saline), INM only (0.2mg/kg of INM concentration 5mg/ml), and INM+L (0.2mg/kg INM with addition of lidocaine 4% based on 25% of midazolam volume). Outcomes included post-anesthesia care unit times, observed behavioral distress (OBD) visual analog scale (VAS) (by nurse and parent), and sedation scores by certified registered nurse anesthetist (CRNA) and registered nurse (RN). RESULTS: Forty-two subjects were included, 14 in each group, with 52% female, 41% physical status 2, and an average age of 2.7 years. Post-anesthesia care unit times averaged 36.5 minutes (range 15-132 minutes), with no delay in discharge with INM or INM+L versus placebo (p=0.88). Verbal complaints were highest among INM+L at the time of administration (p=0.01). RN-scored OBD at one minute post administration differed significantly across the three groups (p=0.01). Parental OBD scores did not differ across treatment groups. Agitation was greatest at time of induction of anesthesia in the placebo group (p=0.01). CONCLUSIONS: The addition of licodaine to INM does not adversely influence time to discharge and does not reduce side effects, improve efficacy, or change duration of action of INM.
RESUMEN
Fusing topical pharyngeal anesthetics (TPAs) to intravenous sedation during esophagogastroduodenoscopy (EGD) has been controversial. This double-blind, randomized, placebo-controlled trial assessed the association of TPA with patient recovery time, post-EGD to discharge. Supplementary aims were to determine the association of TPA with patient and practitioner satisfaction (both measured on a 100-mm visual analog scale), total propofol dose, and side effects. The study included 93 patients (mean age 53.8 years, range 44-67; 37 men and 56 women) undergoing elective EGD at a single academic medical center from September 2015 to October 2016. Urgent or therapeutic EGDs were excluded. Interventions were 7.5 mL 2% lidocaine viscous solution and 7.5 mL placebo solution (3% methylcellulose). There were no statistically significant differences between the lidocaine (n = 46) and placebo (n = 47) groups with respect to recovery time (42 ± 17.8 vs 39 ± 15.9 minutes; P = 0.23), procedure time (6.5 ± 2.7 vs 7 ± 3.6 minutes; P = 0.77), endoscopist satisfaction (83.2 ± 24.4 vs 77 ± 27.7, P = 0.23), patient discomfort (16.6 ± 19.8 vs 24.0 ± 29.7, P = 0.37), or total propofol administered (2.3 ± 1.3 vs 2.3 ± 1.0 mg/kg, P = 0.55). Compared to placebo, topical viscous lidocaine does not appear to delay recovery time or adversely affect sedation-related outcomes.