ABSTRACT
OBJECTIVES: We aimed to describe the quality of sedation and additional clinically-meaningful outcomes associated with different intranasal dexmedetomidine-based regimens in children undergoing nonpainful procedures. METHODS: A multicenter prospective observational study of children aged 2 months to 17 years undergoing intranasal dexmedetomidine sedation for MRI, auditory brainstem response testing, echocardiogram, EEG, or computed tomography scan. Regimens varied by dose of dexmedetomidine and use of adjunct sedatives. Quality of sedation was assessed using the Pediatric Sedation State Scale and by determining proportion of children who achieved an acceptable sedation state. Procedure completion, time-based outcomes, and adverse events were assessed. RESULTS: We enrolled 578 children across 7 sites. Median age was 2.5 years (interquartile range 1.6-3) and 37.5% were female. The most common procedures were auditory brainstem response testing (54.3%) and MRI (22.8%). The most common dose was 3 to 3.9 mcg/kg (55%), with 25.1% and 14.2% of children receiving oral or intranasal midazolam, respectively. Acceptable sedation state and procedure completion was achieved in 81.1% and 91.3% of children, and mean time to onset of sedation and total sedation time were 32.3 and 114.8 minutes, respectively. Twelve interventions were performed in 10 patients in response to an event; no patients required a serious airway, breathing, or cardiovascular intervention. CONCLUSIONS: Intranasal dexmedetomidine-based regimens can achieve acceptable sedation states and high rates of procedure completion in children undergoing sedation for nonpainful procedures. Our findings delineate clinical outcomes associated with intranasal dexmedetomidine-based sedation that can be used to guide the implementation and optimization of such regimens.
Subject(s)
Dexmedetomidine , Humans , Child , Female , Child, Preschool , Male , Dexmedetomidine/adverse effects , Hypnotics and Sedatives , Midazolam , Magnetic Resonance Imaging , Administration, IntranasalABSTRACT
Objective: Although numerous intravenous sedative regimens have been documented, the ideal non-parenteral sedation regimen for magnetic resonance imaging (MRI) has not been determined. This prospective, interventional study aimed to investigate the efficacy and safety of buccal midazolam in combination with intranasal dexmedetomidine in children undergoing MRI. Methods: Children between 1 month and 10 years old requiring sedation for MRI examination were recruited to receive buccal midazolam 0.2 mgâ kg-1 with intranasal dexmedetomidine 3 µgâ kg-1. The primary outcome was successful sedation following the administration of the initial sedation regimens and the completion of the MRI examination. Results: Sedation with dexmedetomidine-midazolam was administered to 530 children. The successful sedation rate was 95.3% (95% confidence interval: 93.5-97.1%) with the initial sedation regimens and 97.7% (95% confidence interval: 96.5-99%) with a rescue dose of 2 µgâ kg-1 intranasal dexmedetomidine. The median sedation onset time was 10 min, and a significant rising trend was observed in the onset time concerning age (R = 0.2491, P < 0.001). The wake-up and discharge times significantly correlated with the duration of the procedure (R = 0.323, P < 0.001 vs. R = 0.325, P < 0.001). No oxygen deficiency nor medication intervention due to cardiovascular instability was observed in any of the patients. History of a prior failed sedation was considered a statistically significant risk factor for failed sedation in the multivariate logistic regression model [odds ratio = 4.71 (95% confidence interval: 1.24-17.9), P = 0.023]. Conclusion: In MRI examinations, the addition of buccal midazolam to intranasal dexmedetomidine is associated with a high success rate and a good safety profile. This non-parenteral sedation regimen can be a feasible and convenient option for short-duration MRI in children between 1 month and 10 years.
ABSTRACT
BACKGROUND: Acquisition of transthoracic echocardiographic (TTEcho) images in children often requires sedation. The optimal sedative for TTEcho has not been determined. Children with congenital heart disease are repeatedly exposed to sedatives and anesthetics that may affect brain development. Dexmedetomidine, which in animals alters brain structure to a lesser degree, may offer advantages in this vulnerable population. METHODS: A prospective, randomized, double-blind trial enrolled 280 children 3-24 months of age undergoing outpatient TTEcho, comparing 2.5 µg·kg intranasal dexmedetomidine to 5 mg·kg oral pentobarbital. Rescue sedation, for both groups, was intranasal dexmedetomidine 1 µg·kg. The primary outcome was adequate sedation within 30 minutes without rescue sedation, assessed by blinded personnel. Secondary outcomes included number of sonographer pauses, image quality in relation to motion artifacts, and parental satisfaction. RESULTS: Success rates with a single dose were not different between sedation techniques; 85% in the pentobarbital group and 84% in the dexmedetomidine group (P = .8697). Median onset of adequate sedation was marginally faster with pentobarbital (16.5 [interquartile range, 13-21] vs 18 [16-23] minutes for dexmedetomidine [P = .0095]). Time from drug administration to discharge was not different (P = .8238) at 70.5 (64-83) minutes with pentobarbital and 70 (63-82) minutes with dexmedetomidine. Ninety-five percent of sedation failures with pentobarbital and 100% of dexmedetomidine failures had successful rescue sedation with intranasal dexmedetomidine. CONCLUSIONS: Intranasal dexmedetomidine was comparable to oral pentobarbital sedation for TTEcho sedation in infants and did not increase the risk of clinically important adverse events. Intranasal dexmedetomidine appears to be an effective "rescue" sedative for both failed pentobarbital and dexmedetomidine sedation. Dexmedetomidine could be a safer option for repeated sedation in children, but further studies are needed to assess long-term consequence of repeated sedation in this high-risk population.
