Randomized clinical trial to assess pain and bruising in medicines administered by means of subcutaneous and intramuscular needle injection: Is it necessary to have needles changed?

Abstract

This clinical trial aimed at comparing the intensity of pain and bruising by subcutaneous and intramuscular injections using and retractable fixed syringes and needles and syringes with no needles combined, at a public hospital in Sao Paulo, for six months. We evaluated the perception of pain in case of intramuscular (n=1000) and subcutaneous injections (n=240).In subcutaneous application, bruise formation was also verified. Pain and bruising scores were higher in the group with no needles combined (p<0.001) and (p<0.029), respectively. Este ensaio clínico teve como objetivo comparar a intensidade da dor e hematoma consequentes a injeções por via subcutânea e intramuscular, utilizando seringas e agulhas fixas retráteis e seringas com agulhas não conjugadas, em hospital público na cidade de São Paulo, durante seis meses. Foi avaliada a percepção da dor na injeção intramuscular (n=1.000) e na subcutânea (n=240). Na aplicação por via subcutânea, verificou-se também a formação de hematoma. A pontuação de dor e hematoma foi maior no grupo com agulhas não conjugadas (p<0,001 e p<0,029, respectivamente). O poder do teste em relação à escala de dor foi de 0,98. Recomenda-se o uso de agulha fixa retrátil na aplicação de injeções intramusculares e subcutâneas. Registro de ensaio clínico nº NCT01271608. Ensayo clínico aleatorio para evaluación del dolor y hematoma durante la administración de medicamentos por vía subcutánea e intramuscular: ¿Es necesario cambiar las agujas?Este ensayo clínico tuvo como objetivo comparar la intensidad del dolor y hematoma de inyecciones por vía subcutánea e intramuscular utilizando jeringas y agujas fijas retráctiles y jeringas con agujas no conjugadas, en un hospital público en la ciudad de Sao Paulo, durante seis meses. Fue evaluada la percepción del dolor de la inyección intramuscular (n=1000) y la subcutánea (n=240). En la aplicación por vía subcutánea se verificó también la formación de hematoma. La puntuación del dolor y hematoma fue mayor en el Grupo con agujas no conjugadas (p<0,001) y (p<0,029), respectivamente.El poder de la prueba en relación a la escala de dolor fue de 0,98. Se recomienda el uso de aguja fija retráctil en la aplicación de inyecciones intramusculares y subcutáneas.Registro de ensayo clínico nº NCT01271608.

Avaliação ultraestrutural de agulhas e seu papel no conforto durante a administração subcutânea de medicamentos

“…Thus, within the sample obtained during the pilot study, it was not possible to infer a correlation between the perception of discomfort and the techniques used to prepare the subcutaneous injections. These results are concordant with those observed in a previous study, which also found no significant relationship between the "conventional" and "emergent" techniques, and the perception of pain by the participants in that study (17) . Thus, it may be suggested that the perception of comfort/ discomfort in these cases seems to be more related to the development of the technique by the nurse and to different intrinsic factors than by the use of needles whose bevels were damaged during drug preparation.…”

“…Although the data obtained in this study reaffirmed the results of the randomized trial previously conducted by another study (17) with 240 patients, the low sampling of this pilot study may be considered a limitation. Thus, new trials, preferably multicentric ones, and with a greater number of participants, should be considered.…”

“…In this randomized study (also with 50 participants), there was a significant difference in the perception of pain when comparing "conventional" and "emergent" techniques (20) . However, the same result could not be observed during a randomized trial in another study (17) involving subcutaneous administration of drugs. This work raises doubts regarding the possibility of comparing the data obtained with the two techniques of subcutaneous drug administration -"conventional" and "emerging" -because the trial was not blinded, the possible unconscious interference of the researcher in the results observed (13 x 0.45 mm and 12.7 x 0.4 mm), and the comparison of pain perception among different individuals (randomization).…”

“…However, a broad and exhaustive search of the main international databases (LILACS, IBECS, MEDLINE, Cochrane Library, SciELO, and CINAHL) using the terms "subcutaneous" and "needle" revealed, from more than 8,000 records, only one trial related to the impact of needle change on the perception of pain during subcutaneous drug administration (17) . In addition, the impact of needle change between aspiration and administration of subcutaneous heparin was assessed in one study (18) regarding bruising formation, but without contemplating the appearance of pain/discomfort.…”

Subcutaneous Administration of Bortezomib: A Pilot Survey of Oncology Nurses

“…Studies in non-oncology fields have addressed the use of different needle sizes and lengths for SC injection (Akkus, Oguz, Uzunlulu, & Kizilgul, 2012;Arendt-Nielsen, Egekvist, & Bjerring, 2006;Birkebaek et al, 2008;Frid et al, 2010;Gibney, Arce, Byron, & Hirsch, 2010;Gill & Prausnitz, 2007;Hunter, 2008;McConnell, 1990;Pope, 2002;Rushing, 2004;Hansen & Matytsina, 2011), the use of dry needles and the air-bubble technique (Agac & Gunes, 2011;Frid et al, 2010;Hunter, 2008;Klingman, 2000;Kurtin, Knop, & Milliron, 2012;Lamblet, Meira, Torres, Ferreira, & Martucchi, 2011;Moore et al, 2007;Wooldridge & Jackson, 1988), the angle of insertion (Akkus et al, 2012;Gibney et al, 2010), and the duration of the SC injection (Balci Akpinar & Celebioglu, 2008;Zaybak & Khorshid, 2008).…”