RESUMEN
OBJECTIVE: To compare injection pain after subcutaneous administration of four different solution volumes. DESIGN: Double-blind, randomized, prospective, multiple crossover study. SETTING: Steno Diabetes Center, Gentofte, Denmark. PARTICIPANTS: Eighteen healthy volunteers, 9 women and 9 men, aged 21-30 years. METHODS: 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). RESULTS: 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). CONCLUSIONS: 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.
Asunto(s)
Inyecciones Subcutáneas , Dimensión del Dolor , Adulto , Método Doble Ciego , Femenino , Humanos , Inyecciones , Insulina/administración & dosificación , MasculinoRESUMEN
The long-term (1) effect of multiple insulin injections in clinical practice was evaluated prospectively in 168 unselected consecutive insulin-dependent diabetic patients, age 31 (10-77) yr, attending a diabetic clinic. All patients received three or more daily injections of short acting insulin using a pen injector (NovoPen) plus one injection of intermediate acting insulin at bedtime. Haemoglobin A1c remained nearly unchanged, baseline: 8.6 (5.7-11.8)%, and after intensified treatment for 12 months: 8.3 (5.7-12.3)%. The frequency of keto-acidosis (0.08 (conventional treatment) versus 0.02 episodes/patient/yr, p less than 0.05) and severe hypoglycaemia (0.69 (conventional treatment) versus 0.38 episodes/patient/yr, p less than 0.005) diminished during intensified treatment. Ninety percent of the patients reported improvement in general well-being and only three percent felt worse. We conclude that multiple insulin injections with a pen injector applied in clinical practice improves general well-being, diminishes the risk of acute metabolic complications, while the overall metabolic control as reflected by haemoglobin A1c remains unaltered.