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Pediatric emergency care · Jan 2022
Randomized Controlled TrialComparison Between a Color-only Method and a Food and Drug Administration-approved Validation Method for a Pediatric Color-coded Syringe Using Midazolam: A Randomized Crossover Trial.
- Caitlin M Howard, Kristine L Jeffers, Allyson A Arana, Diana Montez, and Stephen J Rahm.
- From the San Antonio Uniformed Services Health Education Consortium Military EMS and Disaster Medicine.
- Pediatr Emerg Care. 2022 Jan 1; 38 (1): 172117-21.
ObjectiveThe objective of this study was to assess the use of a color-only method syringe for accuracy and timeliness when administrating midazolam. This method was compared with a U.S. Food and Drug Administration (FDA)-approved validation method.MethodsA prospective, randomized, crossover trial was conducted to compare the dosing accuracy and timeliness of the color-only syringe method versus the validation method. Twenty-five participants prepared pediatric midazolam doses according to their preferred method, a FDA-approved validation method, and a color-only method. Primary endpoints included dosing accuracy and time to medication administration.ResultsThe preferred 3-kg calculations had a median margin of error of 5.6% and a median time to completion of 55.6 seconds. The color-only method took less time to complete than the validation method (median time: 29.5 seconds vs 58.2 seconds). There was no statistically significant difference in errors between the color-only method and the validation method. None of the participants reported a mistake using the color-only method, whereas 25% (5/20) reported a mistake using the validation method. Only 20% (4/20) of participants believed that the validation method found or eliminated any mistakes. There were 8 medication errors identified when participants used the method of choice, 4 with the validation method, and 1 with the color-only method.ConclusionsThere was no significant difference in dosing errors between the FDA-approved validation method and the color-only method. Use of a color-only method did reduced time to medication administration when compared with a preferred method and an FDA-approved validation method.Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.
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