Diphenhydramine in Catheter Related Bladder Discomfort | NCT06345261

Studies
Diphenhydramine in Catheter Related Bladder Discomfort

NCT06345261

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Apr 3, 2024Actual

Enrollment

104Estimated

Phase

Not Applicable

Conditions

Catheter Complications

Interventions

DiphenhydrAMINE 50 Mg/mL Injectable Solution
Saline

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Estimated

Primary Completion Date

Apr 1, 2025Estimated

Completion Date

May 1, 2025Estimated

First Submitted Date

Mar 28, 2024

First Submission Date that Met QC Criteria

Mar 28, 2024

First Posted Date

Apr 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2024

Last Update Posted Date

Apr 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diphenhydramine group	Active Comparator		Drug: DiphenhydrAMINE 50 Mg/mL Injectable Solution
control group	Placebo Comparator		Drug: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DiphenhydrAMINE 50 Mg/mL Injectable Solution	Drug	injection of Diphenhydramine 50 Mg/mL	Diphenhydramine group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
visual analog scale (VAS)	0 (no pain) to 10 (the worst imaginable pain)	up to 6 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amr s wahdan, MD	Cairo university , Cairo, Egypt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo university		Cairo		11562	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

still working

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004155	Diphenhydramine
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D005021	Ethylamines
D000588	Amines
D009930	Organic Chemicals
D001559	Benzhydryl Compounds

Browse Leaves

Not provided

Browse Branches

Not provided