The Effect of Nefopam on Catheter-related Bladder Discomfort

Catheter-related Bladder Discomfort Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130010
• Other study ID #: B-1604/342-006
• Status: Completed
• Phase: N/A
• Start date: March 31, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheter-related Bladder Discomfort
• Nefopam

Intervention

Drug:
• Nefopam 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univ. Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	catheter-related bladder discomfort	assessment of catheter-related bladder discomfort using visual analogue scale	postoperative 1 hour