The Effect of Nefopam on Catheter-related Bladder Discomfort

Seoul National University

Status: Completed

Conditions: Nefopam; Catheter-related Bladder Discomfort

Treatments: Drug: Nefopam or saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03130010

B-1604/342-006

Details and patient eligibility

About

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

Enrollment: 110 patients

Sex: Male

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups, including a placebo group

The control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Nefopam or saline

The Nefopam group

Active Comparator group

Description:

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

Treatment:

Drug: Nefopam or saline