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临床试验/NCT06585748
NCT06585748招募中不适用

The Effect of Lidocaine Spray Use on Patients Comfort in Undergoing Bladder Catheterization: a Prospective,observational ,controlled Study

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Lidocaine and Pain

研究概览

简要总结

Bladder catheterization is a procedure frequently performed in emergency departments and may cause symptoms such as pain and discomfort in patients. This study hypothesizes that lidocaine spray application will improve patient compliance and comfort from the outset and facilitate smoother medical procedures. In our prospective, case-controlled study, the patients were divided into two groups: Group L (lidocaine) and Group P (placebo). Pain conditions after bladder catheterization were evaluated at 0 minutes (during the procedure) and 15, 30 and 60 minutes after the procedure. Face Legs Arm Cry Consolability Pain Scale (FLACC) and Wong-Baker pain scales were used. All time periods in Group L, FLACC score and Wang Baker scores were found to be statistically significantly lower.The differences between the first measurement and the measurements at 15-30-60 minutes of the FLACC score were found to be significantly higher in group P than in group L. As a result, we recommend that lidocaine spray be applied before urinary catheter insertion. This study showed that lidocaine spray increased patients' sleep at the end and reduced the feeling of restlessness by reducing pain.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 92 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • The study included male patients over 18 years old, without trauma, with spontaneous urine output, and who were oriented and cooperative. -

排除标准

  • Exclusion criteria were patients under 18 years old, female patients, patients with trauma, patients with globe vesicale (due to the need for rapid bladder catheterization), patients with anatomical variations, patients with urethral-bladder outlet problems preventing catheterization, and patients who refused to participate in the study.

研究组 & 干预措施

Group L

Group L: Lidocaine spray. Lidocaine spray in our country is available in a 10% spray form, with each puff containing 10 mg of lidocaine. In Group L, 4 puffs of lidocaine spray were applied to the glans penis and urethral meatus, and after 5 minutes, the appropriate method and sterilization were used to apply a catheter gel, and a Foley catheter was placed in the bladder.

干预措施: Lidocaine spray (Drug)

Group P

Group P: Placebo In Group P, 4 puffs of isotonic saline (%0.09 NaCl) spray were applied to the glans penis and urethral meatus, followed by catheter gel application and Foley catheter placement.

干预措施: Placebo (Other)

结局指标

主要结局

Lidocaine and Pain

时间窗: 0., 15., 30., and 60. minutes

The FLACC scale assesses acute pain based on facial expression, leg position, activity, crying, and consolability Each category is scored from 0-2, with 0 indicating a calm patient and 10 indicating a visibly distressed patient .

次要结局

  • Lidocaine and comfort(0., 15., 30., and 60. minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif Kaya Çelikel

MD

Ankara City Hospital Bilkent

研究点 (1)

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