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The Effect of Nefopam on Catheter-related Bladder Discomfort

The Effect of Nefopam on Catheter-related Bladder Discomfort: A Double-blind, Randomized, Controlled, Parallel Design Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03130010
Enrollment
110
Registered
2017-04-26
Start date
2017-03-31
Completion date
2017-12-31
Last updated
2018-04-30

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

Conditions

Catheter-related Bladder Discomfort, Nefopam

Brief summary

In the present study, the investigators evaluated whether nefopam 20 mg reduce the catheter-related bladder discomfort in patients undergoing foley catheter insertion

Interventions

DRUGNefopam or saline

One hour before the end of the operation, the Nefopam group was received 20 mg of nefopam and the saline and the control group was received 20 ml of saline.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
20 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Patients scheduled to insert the catheter a new foley catheter more than 14 Fr in the operation site, 2. Adults 20 to 75years of age 3. American Society of Anesthesiologists Physical Classification 1,2 patients 4. Patients who pre-agreed to the study 5. Male patient

Exclusion criteria

1. Neurogenic bladder 2. Patients diagnosed with irritable bladder 3. study drug sensitive or contraindicated 4. Patients with central nervous system or neurological disorder (epilepsy, patients receiving MAO inhibitor) 5. Patients with urethral and prostate disorders 6. Patients with previous history of myocardial infarction 7. Patients with closed angle glaucoma

Design outcomes

Primary

MeasureTime frameDescription
catheter-related bladder discomfortpostoperative 1 hourassessment of catheter-related bladder discomfort using visual analogue scale

Countries

South Korea

Outcome results

None listed

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