Evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance

Cecile Berteau,1 Orchidée Filipe-Santos,1 Tao Wang,2 Humberto E Rojas,2 Corinne Granger,1 Florence Schwarzenbach1 1Becton-Dickinson Medical Pharmaceutical Systems, Le Pont de Claix, France; 2Eli Lilly and Company, Indianapolis, IN, USA Aim: The primary objective of this study was to eval...

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Autores principales:	Berteau C, Filipe-Santos O, Wang T, Rojas HE, Granger C, Schwarzenbach F
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2015
Materias:	Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/3cbbbb19682a459393b46869b61d16ea
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spelling	oai:doaj.org-article:3cbbbb19682a459393b46869b61d16ea2021-12-02T01:36:23ZEvaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance1179-1470https://doaj.org/article/3cbbbb19682a459393b46869b61d16ea2015-11-01T00:00:00Zhttps://www.dovepress.com/evaluation-of-the-impact-of-viscosity-injection-volume-and-injection-f-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Cecile Berteau,1 Orchidée Filipe-Santos,1 Tao Wang,2 Humberto E Rojas,2 Corinne Granger,1 Florence Schwarzenbach1 1Becton-Dickinson Medical Pharmaceutical Systems, Le Pont de Claix, France; 2Eli Lilly and Company, Indianapolis, IN, USA Aim: The primary objective of this study was to evaluate the impact of fluid injection viscosity in combination with different injection volumes and flow rates on subcutaneous (SC) injection pain tolerance. Methods: The study was a single-center, comparative, randomized, crossover, Phase I study in 24 healthy adults. Each participant received six injections in the abdomen area of either a 2 or 3 mL placebo solution, with three different fluid viscosities (1, 8–10, and 15–20 cP) combined with two different injection flow rates (0.02 and 0.3 mL/s). All injections were performed with 50 mL syringes and 27G, 6 mm needles. Perceived injection pain was assessed using a 100 mm visual analog scale (VAS) (0 mm/no pain, 100 mm/extreme pain). The location and depth of the injected fluid was assessed through 2D ultrasound echography images. Results: Viscosity levels had significant impact on perceived injection pain (P=0.0003). Specifically, less pain was associated with high viscosity (VAS =12.6 mm) than medium (VAS =16.6 mm) or low (VAS =22.1 mm) viscosities, with a significant difference between high and low viscosities (P=0.0002). Target injection volume of 2 or 3 mL was demonstrated to have no significant impact on perceived injection pain (P=0.89). Slow (0.02 mL/s) or fast (0.30 mL/s) injection rates also showed no significant impact on perceived pain during SC injection (P=0.79). In 92% of injections, the injected fluid was located exclusively in SC tissue whereas the remaining injected fluids were found located in SC and/or intradermal layers. Conclusion: The results of this study suggest that solutions of up to 3 mL and up to 15–20 cP injected into the abdomen within 10 seconds are well tolerated without pain. High viscosity injections were shown to be the most tolerated, whereas injection volume and flow rates did not impact perceived pain. Keywords: injection viscosity, injection speed, injection volume, subcutaneous, painBerteau CFilipe-Santos OWang TRojas HEGranger CSchwarzenbach FDove Medical PressarticleMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2015, Iss default, Pp 473-484 (2015)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medical technology R855-855.5
spellingShingle	Medical technology R855-855.5 Berteau C Filipe-Santos O Wang T Rojas HE Granger C Schwarzenbach F Evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance
description	Cecile Berteau,1 Orchidée Filipe-Santos,1 Tao Wang,2 Humberto E Rojas,2 Corinne Granger,1 Florence Schwarzenbach1 1Becton-Dickinson Medical Pharmaceutical Systems, Le Pont de Claix, France; 2Eli Lilly and Company, Indianapolis, IN, USA Aim: The primary objective of this study was to evaluate the impact of fluid injection viscosity in combination with different injection volumes and flow rates on subcutaneous (SC) injection pain tolerance. Methods: The study was a single-center, comparative, randomized, crossover, Phase I study in 24 healthy adults. Each participant received six injections in the abdomen area of either a 2 or 3 mL placebo solution, with three different fluid viscosities (1, 8–10, and 15–20 cP) combined with two different injection flow rates (0.02 and 0.3 mL/s). All injections were performed with 50 mL syringes and 27G, 6 mm needles. Perceived injection pain was assessed using a 100 mm visual analog scale (VAS) (0 mm/no pain, 100 mm/extreme pain). The location and depth of the injected fluid was assessed through 2D ultrasound echography images. Results: Viscosity levels had significant impact on perceived injection pain (P=0.0003). Specifically, less pain was associated with high viscosity (VAS =12.6 mm) than medium (VAS =16.6 mm) or low (VAS =22.1 mm) viscosities, with a significant difference between high and low viscosities (P=0.0002). Target injection volume of 2 or 3 mL was demonstrated to have no significant impact on perceived injection pain (P=0.89). Slow (0.02 mL/s) or fast (0.30 mL/s) injection rates also showed no significant impact on perceived pain during SC injection (P=0.79). In 92% of injections, the injected fluid was located exclusively in SC tissue whereas the remaining injected fluids were found located in SC and/or intradermal layers. Conclusion: The results of this study suggest that solutions of up to 3 mL and up to 15–20 cP injected into the abdomen within 10 seconds are well tolerated without pain. High viscosity injections were shown to be the most tolerated, whereas injection volume and flow rates did not impact perceived pain. Keywords: injection viscosity, injection speed, injection volume, subcutaneous, pain
format	article
author	Berteau C Filipe-Santos O Wang T Rojas HE Granger C Schwarzenbach F
author_facet	Berteau C Filipe-Santos O Wang T Rojas HE Granger C Schwarzenbach F
author_sort	Berteau C
title	Evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance
title_short	Evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance
title_full	Evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance
title_fullStr	Evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance
title_full_unstemmed	Evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance
title_sort	evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance
publisher	Dove Medical Press
publishDate	2015
url	https://doaj.org/article/3cbbbb19682a459393b46869b61d16ea
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_version_	1718402951254376448

Evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance

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