Clinical outcomes of flushing frequency in peripheral catheters of pediatric patients

randomized trial protocol*

Authors

DOI:

https://doi.org/10.1590/ce.v31i0.101982pt

Keywords:

Pediatric Nursing, Child Health, Clinical Trial Protocol, Catheterization, Peripheral, Saline Solution

Abstract

Objective: To verify the superiority of standardized flushing over usual flushing regarding dwell time and incidence of complications in short peripheral intravenous catheters inserted in hospitalized children.

Method: Protocol of a randomized, controlled, open-label, superiority clinical trial in parallel groups. It will be conducted in a pediatric state hospital. Study participants will be allocated to the intervention group, consisting of children who undergo flushing before and after medication administration and every 12 hours, and to the control group, with participants undergoing flushing before and after medication administration. The primary outcome will be catheter dwell time. Data analysis will be descriptive and univariate, with estimation of the survival curve as a function of time.

Final considerations: This protocol is a relevant instrument for presenting the different planning stages of a clinical trial. Brazilian registration number 9mtwh2j.

 

Author Biographies

Érika Ribeiro de Souza, State University of Feira de Santana, BA, Brazil.

Nurse. Master's degree in Pharmaceutical Sciences. Member of the Laboratory for Studies and Research in Innovation and Safety in Healthcare. State University of Feira de Santana, BA, Brazil.

Bianka Sousa Martins Silva, State University of Bahia, Salvador, BA, Brazil.

Nurse. PhD in Sciences. Professor at the State University of Bahia, Salvador, BA, Brazil.

Denise Miyuki Kusahara, Federal University of São Paulo, São Paulo, SP, Brazil.

Nurse. PhD in Sciences. Professor at the Federal University of São Paulo, São Paulo, SP, Brazil.

Isaiane Santos Bittencourt, State University of Bahia, Senhor do Bonfim, BA, Brazil.

Nurse. PhD in Sciences. Professor at the State University of Bahia, Senhor do Bonfim, BA, Brazil.

Patrícia Kuerten Rocha, Federal University of Santa Catarina, Florianópolis, SC, Brazil.

Nurse. Post-doctoral degree in Health Sciences. Professor at the Federal University of Santa Catarina, Florianópolis, SC, Brazil.

Maria Cristina de Camargo, State University of Feira de Santana, Feira de Santana, Bahia, Brazil.

Nurse. PhD in Public Health. Professor at the State University of Feira de Santana, Feira de Santana, Bahia, Brazil.

Luciano Marques dos Santos, State University of Feira de Santana, Feira de Santana, Bahia, Brazil.

Nurse. Doctor of Science. Professor at the State University of Feira de Santana, Feira de Santana, Bahia, Brazil.

References

1. Indarwati F, Mathew S, Munday J, Keogh S. Incidence of peripheral intravenous catheter failure and complications in paediatric patients: systematic review and meta analysis. Int J Nurs Stud [Internet]. 2020 [cited 2025 Jun 5];102:103488. Available from: https://doi.org/10.1016/j.ijnurstu.2019.103488

2. Heydinger G, Shafy SZ, O'Connor C, Nafiu O, Tobias JD, Beltran RJ. Characterization of the difficult peripheral iv in the perioperative setting: a prospective, observational study of intravenous access for pediatric patients undergoing anesthesia. Pediatric Health Med Ther [Internet]. 2022 [cited 2025 Jun 5];13:155-63. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC9081190/

3. Ullman AJ, Takashima M, Kleidon T, Ray-Barruel G, Alexandrou E, Rickard CM. Global pediatric peripheral intravenous catheter practice and performance: a secondary analysis of 4206 catheters. J Pediatr Nurs [Internet]. 2020 [cited 2025 Jun 5];50:e18-e25. Available from: https://doi.org/10.1016/j.pedn.2019.09.023

4. Infusion Nurses Society (INS). Policies and Procedures for Infusion Therapy: Neonate to Adolescent. 4th ed. Massachusetts: Infusion Nurses Society; 2024. 367 p.

5. Tseng JH, Elaine Chen YFE, Chang SP, Wang HC, Kuo YT. Factors affecting the patency and complications of peripheral intravenous catheters in newborns. Pediatr Neonatol [Internet]. 2023 [cited 2025 Jun 5];64(3):239-46. Available from: https://doi.org/10.1016/j.pedneo.2022.07.011

6. Tripathi S, Gladfelter T. Peripheral intravenous catheters in hospitalized patients: Practice, Dwell times, and factors impacting the dwell times: A single center retrospective study. J Vasc Access [Internet]. 2021 [cited 2025 Jun 5];23(4):581-8. Available from: https://doi.org/10.1177/11297298211000874

7. Saliba P, Cuervo G, Hornero A, De Carli de G, Marani A, Puro V, et al. The impact of flushing with pre-filled saline syringes on the incidence of peripheral venous catheter failure: A quasi-experimental study. J Vasc Access [Internet]. 2019 [cited 2025 Jun 13];21(4):490-6. Available from: https://doi.org/10.1177/1129729819888423

8. Liu C, Chen L, Kong D, Lyu F, Luan L, Yang L. Incidence, risk factors and medical cost of peripheral intravenous catheter-related complications in hospitalised adult patients. J Vasc Access [Internet]. 2022 [cited 2025 Jun 13];23(1):57-66. Available from: https://doi.org/10.1177/1129729820978124

9.van Loon FHJ, Leggett T, Bouwman ARA, Daele ATMDV. Cost-utilization of peripheral intravenous cannulation in hospitalized adults: an observational study J Vasc Access [Internet]. 2020 [cited 2025 Jun 13];21(5):687-93. Available from: https://doi.org/10.1177/1129729820901653

10. de la Vieja-Soriano M, Blanco-Daza M, Macip-Belmonte S, Dominguez-Muñoz M, López-Sánchez E, Pérez-Pérez E. Difficult intravenous access in a paediatric intensive care unit. Enferm Intensiva [Internet]. 2021 Jul 7 [cited 2025 Aug 28];33(2):67-76. Available from: https://doi.org/10.1016/j.enfie.2021.03.006

11. Marsh N, Rickard CM. Peripheral intravenous catheter failure-is it us or is it them? Lancet Haematol [Internet]. 2021 [cited 2025 Jun 13];8(9):e615-e7. Available from: https://doi.org/10.1016/S2352-3026(21)00234-9

12. dos Santos LM, Silva CSG, Machado ES, Almeida AHV, da Silva CAL, Silva BSM, et al. Risk factors for site complications of intravenous therapy in children and adolescents with cancer. Rev Bras Enferm [Internet]. 2020 [cited 2025 Jun 13];73(4):e20190471. Available from: https://doi.org/10.1590/0034-7167-2019-0471

13. Marsh N, Larsen EN, Takashima M, Kleidon T, Keogh S, Ullman AJ et al. Peripheral intravenous catheter failure: a secondary analysis of risks from 11,830 catheters. Int J Nurs Stud [Internet]. 2021 [cited 2025 Jun 13];124:104095. Available from: https://doi.org/10.1016/J.IJNURSTU.2021.104095

14. Abdelaziz RB, Hafsi H, Hajji H, Boudabous H, Chehida AB, Mrabet A, et al. Peripheral venous catheter complications in children: predisposing factors in a multicenter prospective cohort study. BMC Pediatr [Internet]. 2017 [cited 2025 Jun 13];17:208. Available from: https://doi.org/10.1186/S12887-017-0965-Y

15. Keogh S, Shelverton C, Flynn J, Mihala G, Mathew S, Davies KM, et al. Implementation and evaluation of short peripheral intravenous catheter flushing guidelines: a stepped wedge cluster randomised trial. BMC Med [Internet]. 2020 [cited 2025 Jun 24];18:252. Available from: https://doi.org/10.1186/S12916-020-01728-1

16. Nickel B, Gorski L, Kleidon T, Kyes A, Devries M, Keogh S et al. Infusion therapy standards of practice, J Infus Nurs [Internet]. 2024 [cited 2025 Jun 28];47(15). 285 p. Available from: https://doi.org/10.1097/NAN.0000000000000532

17. Brasil. Agência Nacional de Vigilância Sanitária [Internet]. Nota técnica no 04/2022. Práticas seguras para a prevenção de incidentes envolvendo cateter intravenoso periférico em serviços de saúde. Brasília, DF: ANVISA; 2022 [cited 2025 oct 01]; 22 p. Available from: https://portaldeboaspraticas.iff.fiocruz.br/atencao-recem-nascido/nt4-cateter-intravenoso-anvisa-2022/

18. Zhu L, Liu H, Wang R, Yu Y, Zheng F, Yin J. Mechanism of pulsatile flushing technique for saline injection via a peripheral intravenous catheter. Clin Biomech [Internet]. 2020 [cited 2025 Jun 28];80:105103. Available from: https://doi.org/10.1016/J.CLINBIOMECH.2020.105103

19. Sotnikova C, Fasoi G, Efstathiou F, Kaba E, Bourazani M, Kelesi M. The efficacy of normal saline (N/S 0.9%) versus heparin solution in maintaining patency of peripheral venous catheter and avoiding complications: a systematic review. Mater Sociomed [Internet]. 2020 [cited 2025 Jun 28];32(1):29-34. Available from: https://pubmed.ncbi.nlm.nih.gov/32410888/

20. Schreiber S, Zanchi C, Ronfani L, Delise A, Corbelli AA, Bortoluzzi R et al. Normal saline flushes performed once daily maintain peripheral intravenous catheter patency: a randomised controlled trial. Arch Dis Child [Internet]. 2015 [cited 2025 Jun 28];100(7):700-3. Available from: https://doi.org/10.1136/ARCHDISCHILD-2014-307478

21. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: Defining standard protocol items for clinical trials. Ann Intern Med [Internet]. 2013 [cited 2025 Jun 28];158(3):200-7. Available from: https://doi.org/10.7326%2F0003-4819-158-3-201302050-00583

22. Becton Dickinson (BD). BD® PosiFlush™ Prefilled Flush Syringes [Internet]. São Paulo:BD; 2024 [cited 2024 jun 24];[about 5 screens]. Available from: https://www.bd.com/en-us/products-and-solutions/products/product-families/bd-posiflush-pre-filled-saline-syringe

Downloads

Published

2026-07-01

How to Cite

de Souza, Érika R., Silva, B. S. M., Kusahara, D. M., Bittencourt, I. S., Rocha, P. K., de Camargo, M. C., & dos Santos, L. M. (2026). Clinical outcomes of flushing frequency in peripheral catheters of pediatric patients: randomized trial protocol*. Cogitare Enfermagem, 31. https://doi.org/10.1590/ce.v31i0.101982pt

Issue

Vol. 31 (2026)

Section

Free Communication

License

Copyright (c) 2026 Érika Ribeiro de Souza, Bianka Sousa Martins Silva, Denise Miyuki Kusahara, Isaiane Santos Bittencourt, Patrícia Kuerten Rocha, Maria Cristina de Camargo, Luciano Marques dos Santos

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Cogitare Enfermagem reserves the right to make normative, orthographic, and grammatical changes to the published article to maintain the cultured standard of the language, while respecting the authors' style.

The published study is the sole responsibility of the author(s), and Cogitare Enfermagem is exclusively responsible for evaluating the manuscript as a scientific publication vehicle. Revista Cogitare Enfermagem is not responsible for any violations of Law No. 9,610/1998, the Brazilian Copyright Law.

Cogitare Enfermagem allows the author to hold the copyright of articles accepted for publication, without restrictions.

The articles published are licensed under the Creative Commons license CC BY 4.0 Creative Commons - Attribution 4.0 International - CC BY 4.0 - The attribution adopted by Cogitare Enfermagem is permitted:

  • Share - copy and redistribute the material in any media or format.
  • Adapt - remix, transform and build upon the material for any purpose, even commercially.
  • Attribution - You must give proper credit, provide a link to the license, and indicate if changes have been made. You may do this in any reasonable way, but not in a way that suggests that the licensor endorses it or approves of its use.
  • No additional restrictions - You may not apply legal terms or technological measures that legally restrict others from doing something that the license allows.