Comparison 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

Objective: The objective of this study was to assess the use of a coloronly 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. Methods: A 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 FDAapproved validation method, and a color-only method. Primary endpoints included dosing accuracy and time to medication administration. Results: The 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. Conclusions: There 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.