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NCT06345261 Clinical Trial

Diphenhydramine in Catheter Related Bladder Discomfort

Catheter Complications Clinical Trial

Official title:
Role of Diphenhydramine in Prevention of Catheter Related Bladder Discomfort

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06345261
Other study ID # 2024-872
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date May 1, 2025

Study information
Verified date March 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Diphenhydramine has H1-antihistamine action, it also possesses anti-muscarinic properties. Thus, diphenhydramine might be able to reduce the problem of catheter related bladder discomfort by inhibiting smooth muscle spasm of the urinary bladder via its anti-muscarinic action .

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 104
Est. completion date May 1, 2025
Est. primary completion date April 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: male patients aged more than18-80 years ASA I and II , upper ureteric stone removal under general anesthesia r Exclusion Criteria: overactive bladder cognitive impairment a neuropsychological disorder, bladder outflow obstruction urinary tract infection, , neurogenic bladder, operative time > 6 h

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DiphenhydrAMINE 50 Mg/mL Injectable Solution
injection of Diphenhydramine 50 Mg/mL
• Saline
injection of saline

Locations
Country Name City State
Egypt Cairo university Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of catheter related bladder discomfort postoperative none, did not complain of any CRBD even upon asking.
mild, revealed only on questioning.
moderate, reported without questioning but not accompanied by any behavioral response.
severe, stated on their own and followed by behavioral responses such as a strong verbal response, flailing limbs, and even attempting to pull out the urinary catheter		 UP TO 6 HOURE
Secondary visual analog scale (VAS) 0 (no pain) to 10 (the worst imaginable pain) up to 6 hours
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