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Diphenhydramine in Catheter Related Bladder Discomfort

Role of Diphenhydramine in Prevention of Catheter Related Bladder Discomfort

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06345261
Enrollment
104
Registered
2024-04-03
Start date
2024-04-01
Completion date
2025-05-01
Last updated
2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Complications

Brief 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 .

Interventions

DRUGDiphenhydrAMINE 50 Mg/mL Injectable Solution

injection of Diphenhydramine 50 Mg/mL

DRUGSaline

injection of saline

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of catheter related bladder discomfort postoperativeUP TO 6 HOURE* 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

Secondary

MeasureTime frameDescription
visual analog scale (VAS)up to 6 hours0 (no pain) to 10 (the worst imaginable pain)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026