Daniel S Tsze1, Maria Ieni2, Daniel B Fenster2, John Babineau2, Joshua Kriger3, Bruce Levin3, Peter S Dayan2. 1. Department of Pediatrics, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY. Electronic address: dst2141@columbia.edu. 2. Department of Pediatrics, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY. 3. Department of Biostatistics, Columbia University Medical Center, New York, NY.
Abstract
STUDY OBJECTIVE: The optimal intranasal volume of administration for achieving timely and effective sedation in children is unclear. We aimed to compare clinical outcomes relevant to procedural sedation associated with using escalating volumes of administration to administer intranasal midazolam. METHODS: We conducted a randomized, single-blinded, 3-arm, superiority clinical trial. Children aged 1 to 7 years and undergoinglaceration repair requiring 0.5 mg/kg intranasal midazolam (5 mg/mL) were block-randomized to receive midazolam using 1 of 3 volumes of administration: 0.2, 0.5, or 1 mL. Procedures were videotaped, with outcome assessors blinded to volume of administration. Primary outcome was time to onset of minimal sedation (ie, score of 1 on the University of Michigan Sedation Scale). Secondary outcomes included procedural distress, time to procedure start, deepest level of sedation achieved, adverse events, and clinician and caregiver satisfaction. RESULTS:Ninety-nine children were enrolled; 96 were analyzed for the primary outcome and secondary outcomes, except for the outcome of procedural distress, for which only 90 were analyzed. Time to onset of minimal sedation for each escalating volume of administration was 4.7 minutes (95% confidence interval [CI] 3.8 to 5.4 minutes), 4.3 minutes (95% CI 3.9 to 4.9 minutes), and 5.2 minutes (95% CI 4.6 to 7.0 minutes), respectively. There were no differences in secondary outcomes except for clinician satisfaction with ease of administration: fewer clinicians were satisfied when using a volume of administration of 0.2 mL. CONCLUSION: There was a slightly shorter time to onset of minimal sedation when a volume of administration of 0.5 mL was used compared with 1 mL, but all 3 volumes of administration produced comparable clinical outcomes. Fewer clinicians were satisfied with ease of administration with a volume of administration of 0.2 mL.
RCT Entities:
STUDY OBJECTIVE: The optimal intranasal volume of administration for achieving timely and effective sedation in children is unclear. We aimed to compare clinical outcomes relevant to procedural sedation associated with using escalating volumes of administration to administer intranasal midazolam. METHODS: We conducted a randomized, single-blinded, 3-arm, superiority clinical trial. Children aged 1 to 7 years and undergoing laceration repair requiring 0.5 mg/kg intranasal midazolam (5 mg/mL) were block-randomized to receive midazolam using 1 of 3 volumes of administration: 0.2, 0.5, or 1 mL. Procedures were videotaped, with outcome assessors blinded to volume of administration. Primary outcome was time to onset of minimal sedation (ie, score of 1 on the University of Michigan Sedation Scale). Secondary outcomes included procedural distress, time to procedure start, deepest level of sedation achieved, adverse events, and clinician and caregiver satisfaction. RESULTS: Ninety-nine children were enrolled; 96 were analyzed for the primary outcome and secondary outcomes, except for the outcome of procedural distress, for which only 90 were analyzed. Time to onset of minimal sedation for each escalating volume of administration was 4.7 minutes (95% confidence interval [CI] 3.8 to 5.4 minutes), 4.3 minutes (95% CI 3.9 to 4.9 minutes), and 5.2 minutes (95% CI 4.6 to 7.0 minutes), respectively. There were no differences in secondary outcomes except for clinician satisfaction with ease of administration: fewer clinicians were satisfied when using a volume of administration of 0.2 mL. CONCLUSION: There was a slightly shorter time to onset of minimal sedation when a volume of administration of 0.5 mL was used compared with 1 mL, but all 3 volumes of administration produced comparable clinical outcomes. Fewer clinicians were satisfied with ease of administration with a volume of administration of 0.2 mL.
Authors: Nicole M L Veldhorst-Janssen; Audrey A A Fiddelers; Paul-Hugo M van der Kuy; Cees Neef; Marco A E Marcus Journal: Clin Ther Date: 2009-12 Impact factor: 3.393
Authors: Daniel S Tsze; Dale W Steele; Jason T Machan; Fatemeh Akhlaghi; James G Linakis Journal: Pediatr Emerg Care Date: 2012-08 Impact factor: 1.454
Authors: Francisco Javier Gómez-Manzano; José Alberto Laredo-Aguilera; Ana Isabel Cobo-Cuenca; Joseba Rabanales-Sotos; Sergio Rodríguez-Cañamero; Noelia Martín-Espinosa; Juan Manuel Carmona-Torres Journal: Children (Basel) Date: 2022-04-29
Authors: Nicole C O'Connell; Hilary A Woodward; Pamela L Flores-Sanchez; Son H McLaren; Maria Ieni; Kenneth W McKinley; Sripriya T Shen; Peter S Dayan; Daniel S Tsze Journal: J Am Coll Emerg Physicians Open Date: 2020-08-26