Jørgensen J T, Rømsing J, Rasmussen M, Møller-Sonnergaard J, Vang L, Musaeus L
Department of Pharmaceutics, Royal Danish School of Pharmacy, Copenhagen, Denmark.
Ann Pharmacother. 1996 Jul-Aug;30(7-8):729-32. doi: 10.1177/106002809603000703.
To compare injection pain after subcutaneous administration of four different solution volumes.
Double-blind, randomized, prospective, multiple crossover study.
Steno Diabetes Center, Gentofte, Denmark.
Eighteen healthy volunteers, 9 women and 9 men, aged 21-30 years.
The subjects were injected with four different volumes (0.2, 0.5, 1.0, 1.5 mL) of NaCl 0.9%. The study was performed on 2 days with a 1-week washout period between the study days. On each study day the subjects received four injections in each thigh. To evaluate the validity of our pain assessing model the subjects received eight injections of 0.5% mL on one of the study days. Pain assessment was done immediately after each injection using both a 10-cm visual analog scale (VAS) and a six-item verbal rating scale (VRS).
A significant difference in pain score on both the VAS (p < 0.05) and the VRS (p < 0.01) was seen between the four injection volumes. The pain was significantly increased with volumes of 1.0 and 1.5 mL. No significant difference in injection pain could be detected between 0.2 and 0.5 mL and between 1.0 and 1.5 mL. No significant period or carryover effect could be detected in the study. A significant correlation between the pain score on the VAS and the pain score on the VRS was found (r = 0.79, p < 0.0001).
The pain of a subcutaneous injection is related to injection volume in the thigh. The results show that increasing the volume from 0.5 to 1.0 mL increases the pain significantly. The findings from this study should be considered when injection preparations for subcutaneous administration are formulated. The volume should generally be less than 1.0 mL if injected into the thigh.
比较皮下注射四种不同溶液体积后的注射疼痛情况。
双盲、随机、前瞻性、多次交叉研究。
丹麦根措夫特的斯泰诺糖尿病中心。
18名健康志愿者,9名女性和9名男性,年龄在21至30岁之间。
受试者被注射四种不同体积(0.2、0.5、1.0、1.5毫升)的0.9%氯化钠溶液。研究在2天内进行,研究日之间有1周的洗脱期。在每个研究日,受试者每条大腿接受四次注射。为评估我们疼痛评估模型的有效性,受试者在其中一个研究日接受八次0.5毫升的注射。每次注射后立即使用10厘米视觉模拟量表(VAS)和六项语言评定量表(VRS)进行疼痛评估。
四种注射体积在VAS(p < 0.05)和VRS(p < 0.01)上的疼痛评分存在显著差异。1.0毫升和1.5毫升体积时疼痛显著增加。0.2毫升和0.5毫升之间以及1.0毫升和1.5毫升之间未检测到注射疼痛的显著差异。研究中未检测到显著的周期或残留效应。发现VAS上的疼痛评分与VRS上的疼痛评分之间存在显著相关性(r = 0.79,p < 0.0001)。
皮下注射的疼痛与大腿的注射体积有关。结果表明,体积从0.5毫升增加到1.0毫升时疼痛显著增加。在配制皮下注射制剂时应考虑本研究的结果。如果注射到大腿,体积一般应小于1.0毫升。