Kozer Eran, Rosenbloom Ehud, Goldman Dorit, Lavy Gila, Rosenfeld Noa, Goldman Michael
Pediatric Emergency Medicine, Assaf Harofeh Medical Center, Tel Aviv, Israel.
Pediatrics. 2006 Jul;118(1):e51-6. doi: 10.1542/peds.2005-2326.
Proper diagnosis of urinary tract infections depends on obtaining an uncontaminated urine sample for culture. Suprapubic aspiration and transurethral catheterization are the 2 recommended procedures for obtaining specimens for urine culture from young infants. The objective of the current study was to compare the pain that is experienced during these 2 procedures when performed in young infants.
A prospective, single-blind, randomized, controlled study was conducted at a university-affiliated hospital in Israel. Institutional Research Ethics Board approved the study. Infants who were 0 to 2 months of age and presented to the emergency department with fever and therefore required urine collection for culture were randomly assigned evenly into 2 sample collection groups: suprapubic aspiration or transurethral catheterization. Patients were excluded when they were born prematurely or had had a previous sepsis workup or other painful procedures or an anomaly of the urogenital system or abdominal wall. Eutectic mixture of local anesthetic cream that contained lidocaine and prilocaine was applied 1 hour before the procedure. The urethra was catheterized using a 5-Fr latex-free feeding tube that was lubricated with sterile water-soluble jelly that contained 2% lidocaine hydrochloride. Pediatric residents who were experienced with the procedures performed both suprapubic aspiration and transurethral catheterization. The parents were instructed to use any comfort strategies that they wished, including verbal or physical comforting and pacifiers. Pain during collection was assessed on a 100-mm visual analog scale by a nurse and a parent. In addition, the infant's upper part of the body was videotaped during the procedure. An investigator, who was blinded to the procedure, assigned a point score according to the Douleur Aigue du Nouveaune neonatal acute pain scale. For ensuring a successful blinding process, the following steps were taken. First, camera recording started 30 seconds before the procedure to prevent the possibility of distinguishing between the procedures on the basis of their duration. Second, the physician and the nurse were asked not to speak during the procedure to avoid revealing the nature of the procedure. Third, the person who videotaped the procedure watched the tape before it was analyzed to ensure the impossibility of identifying the procedure from the tape. The Student's t test was used to compare the groups. The primary outcome was the mean Douleur Aigue du Nouveaune score. Secondary outcomes were the mean visual analogue scale for pain as estimated by the parents and by the nurse. We estimated that 25 patients would be needed in each group to detect a difference in the mean Douleur Aigue du Nouveaune score of at least 2 points with a power of 80% and alpha of .05.
The study was conducted between April 1, 2004, and April 30, 2005. Fifty-eight infants were recruited; 29 were randomly assigned to suprapubic aspiration, and 29 were randomly assigned to transurethral catheterization. Seven infants were excluded because of consent withdrawal (3 patients), because of technical difficulties during videotaping (3 patients), or because the child voided during the procedure (1 patient). Twenty-seven infants in the suprapubic aspiration group and 24 in the transurethral catheterization group completed the study. All male infants were circumcised. An adequate urine sample was obtained in 18 (66%) of 27 patients in the suprapubic aspiration group and in 20 (83.3%) of 24 in the transurethral catheterization group. The mean Douleur Aigue du Nouveaune score was significantly higher in patients who were randomly assigned to suprapubic aspiration compared with patients who were randomly assigned to transurethral catheterization (7 and 4.5, respectively). The differences in Douleur Aigue du Nouveaune score also were significant in a subgroup analysis of boys and girls. Mean visual analogue scale scores by parents was higher in the suprapubic aspiration group compared with transurethral catheterization (63 +/- 27 mm vs 46 +/- 26, respectively). Similarly, mean visual analogue scale scores by nurses was higher in the suprapubic aspiration group compared with transurethral catheterization (3 +/- 18 mm vs 43 +/- 25 mm, respectively).
In infants who are younger 2 months, suprapubic aspiration is more painful than transurethral catheterization. Health professionals should consider these differences when choosing a method for obtaining a urine sample from young infants.
正确诊断尿路感染依赖于获取未受污染的尿液样本进行培养。耻骨上穿刺抽吸术和经尿道导尿术是从婴幼儿获取尿液培养标本的两种推荐方法。本研究的目的是比较这两种方法在婴幼儿中实施时所经历的疼痛程度。
在以色列一家大学附属医院进行了一项前瞻性、单盲、随机对照研究。机构研究伦理委员会批准了该研究。年龄在0至2个月、因发热就诊于急诊科且因此需要采集尿液进行培养的婴儿被随机平均分为2个样本采集组:耻骨上穿刺抽吸组或经尿道导尿组。出生时早产、既往有败血症检查或其他痛苦操作、或存在泌尿生殖系统或腹壁异常的患者被排除。在操作前1小时涂抹含利多卡因和丙胺卡因的局部麻醉膏。使用一根5F无乳胶喂养管经尿道插管,该喂养管用含2%盐酸利多卡因的无菌水溶性凝胶润滑。熟悉这些操作的儿科住院医师进行耻骨上穿刺抽吸术和经尿道导尿术。指导家长使用他们希望的任何安抚策略,包括言语或身体安抚以及安抚奶嘴。由一名护士和一名家长通过100毫米视觉模拟量表评估采集过程中的疼痛。此外,在操作过程中对婴儿的上半身进行录像。一名对操作不知情的研究者根据新生儿急性疼痛评分量表(Douleur Aigue du Nouveau - né)进行评分。为确保成功实施盲法,采取了以下步骤。首先,在操作前30秒开始摄像,以防止根据操作持续时间区分操作。其次,要求医生和护士在操作过程中不说话,以避免透露操作性质。第三,录像者在分析录像带之前观看录像带,以确保无法从录像中识别操作。采用学生t检验比较两组。主要结局是新生儿急性疼痛评分量表的平均得分。次要结局是家长和护士估计的疼痛视觉模拟量表平均分。我们估计每组需要25名患者,以80%的检验效能和0.05的α水平检测新生儿急性疼痛评分量表平均得分至少相差2分的差异。
研究于2004年4月1日至2005年4月30日进行。招募了58名婴儿;29名被随机分配到耻骨上穿刺抽吸组,29名被随机分配到经尿道导尿组。7名婴儿因撤回同意(3例)、录像时出现技术困难(3例)或操作过程中患儿排尿(1例)而被排除。耻骨上穿刺抽吸组27名婴儿和经尿道导尿组24名婴儿完成了研究。所有男婴均已行包皮环切术。耻骨上穿刺抽吸组27例患者中有18例(66%)获得了足够的尿液样本,经尿道导尿组24例患者中有20例(83.3%)获得了足够的尿液样本。与随机分配到经尿道导尿组的患者相比,随机分配到耻骨上穿刺抽吸组的患者新生儿急性疼痛评分量表平均得分显著更高(分别为7分和4.5分)。在男孩和女孩的亚组分析中,新生儿急性疼痛评分量表得分的差异也具有显著性。耻骨上穿刺抽吸组家长的疼痛视觉模拟量表平均分高于经尿道导尿组(分别为63±27毫米和46±26毫米)。同样,耻骨上穿刺抽吸组护士的疼痛视觉模拟量表平均分高于经尿道导尿组(分别为3±18毫米和43±25毫米)。
在2个月以下的婴儿中,耻骨上穿刺抽吸术比经尿道导尿术更痛苦。卫生专业人员在为婴幼儿选择获取尿液样本的方法时应考虑这些差异。