Hui Liu1,2,3,4, Mang Sun1,2,3,4, Jing Zhang1,2,3,4, Qin Tian1, Qing Yu1,2,3,4, Yang Liu1,2,3,4, Fei Yang1, Shangyingying Li1, Shengfen Tu1. 1. Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China. 2. Ministry of Education Key Laboratory of Child Development and Critical Disorders, Chongqing, China. 3. China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing, China. 4. Chongqing Key Laboratory of Pediatrics, Chongqing, China.
Abstract
BACKGROUND: The intranasal route of dexmedetomidine (DEX) administration is becoming increasingly popular for providing adequate sedation during short examinations in infants and children. However, data on the 90% effective dose (ED90) of intranasal DEX are rare in children under 3 years old. METHODS: This is a double-blind trial using a biased coin design up-and-down sequential method (BCD-UDM). Fifty-three children aged under 3 years old requiring DEX for EEG were included in our study. The first patient received 2.5 μg kg-1 DEX, and the dose of DEX administered to the subsequent patient was determined by the response of the previous patient. The patient responses were recorded and analysed to calculate the ED90 by isotonic regression. The 95% confidence interval (CI) was estimated using a bootstrapping method. RESULTS:Fifty-three patients were included in our study, of which 45 patients were successfully sedated, and the 8 instances of failed sedation were rescued usingsevoflurane inhalation, allowing the completion of the procedure. The 90% effective dose of DEX was calculated to be 3.28 µg kg-1 , and the 95% CI was 2.74 ~ 3.39 µg kg-1 . No significant adverse events occurred in any of the patients. CONCLUSION: The 90% effective dose of intranasal DEX sedation for EEG was 3.28 μg kg-1 in children under 3 years old.
RCT Entities:
BACKGROUND: The intranasal route of dexmedetomidine (DEX) administration is becoming increasingly popular for providing adequate sedation during short examinations in infants and children. However, data on the 90% effective dose (ED90) of intranasal DEX are rare in children under 3 years old. METHODS: This is a double-blind trial using a biased coin design up-and-down sequential method (BCD-UDM). Fifty-three children aged under 3 years old requiring DEX for EEG were included in our study. The first patient received 2.5 μg kg-1 DEX, and the dose of DEX administered to the subsequent patient was determined by the response of the previous patient. The patient responses were recorded and analysed to calculate the ED90 by isotonic regression. The 95% confidence interval (CI) was estimated using a bootstrapping method. RESULTS: Fifty-three patients were included in our study, of which 45 patients were successfully sedated, and the 8 instances of failed sedation were rescued using sevoflurane inhalation, allowing the completion of the procedure. The 90% effective dose of DEX was calculated to be 3.28 µg kg-1 , and the 95% CI was 2.74 ~ 3.39 µg kg-1 . No significant adverse events occurred in any of the patients. CONCLUSION: The 90% effective dose of intranasal DEX sedation for EEG was 3.28 μg kg-1 in children under 3 years old.