Lidocaine Spray Use on Patients Comfort in Undergoing Bladder Catheterization

NCT ID: NCT06585748

Last Updated: 2024-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Catheterization As the Cause of Abnormal Reaction of Patient, or of Later Complication, Without Mention of Misadventure At Time of Procedure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Lidocaine spray

Intervention Type DRUG

4 puffs of lidocaine spray was 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. After bladder catheterization, pain scores were evaluated by a neutral emergency medicine physician at 0 minutes (during the procedure), and at 15, 30, and 60 minutes post-procedure. The Face Legs Arms Cry Consolability Pain Scale (FLACC) and Wong-Baker pain scales were used for this evaluation.

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.

Placebo

Intervention Type OTHER

No medication/application will be administered as placebo.

Interventions

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Lidocaine spray

4 puffs of lidocaine spray was 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. After bladder catheterization, pain scores were evaluated by a neutral emergency medicine physician at 0 minutes (during the procedure), and at 15, 30, and 60 minutes post-procedure. The Face Legs Arms Cry Consolability Pain Scale (FLACC) and Wong-Baker pain scales were used for this evaluation.

Intervention Type DRUG

Placebo

No medication/application will be administered as placebo.

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

92 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Elif Kaya Çelikel

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Etlik City Hospital

Ankara, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Elif Çelikel, MD

Role: primary

+905058310158

Ahmet Burak Erdem, Asosc. Prof.

Role: backup

+905054957495

Other Identifiers

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ACH-Lidocaine

Identifier Type: -

Identifier Source: org_study_id

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