Prophylactic tramadol versus nefopam for post-operative catheter -related bladder discomfort in patients undergoing elective per-cutaneous nephrolithotomy

Prophylactic tramadol versus nefopam for post-operative catheter-related bladder discomfort in patients undergoing elective per-cutaneous nephrolithotomy.A randomized controlled trial

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618002054291

Acronym

T vs. N in PCNL

Enrollment

150

Registered

2018-12-21

Start date

2017-07-01

Completion date

2018-07-02

Last updated

2019-01-14

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

Conditions

None listed

Brief summary

This study is conducted to compare the administration of iv tramadol and nefopam for prophylactic treatment of catheter related bladder discomfort for patients undergoing elective per cutaneous nephrolithotomy

Interventions

3 groups are included in which a total volume of 10 ml. Isotonic saline ( 0.9%) are given slow intravenously (Over 1 min.) 30 min. Before expected extubation Group I: tramadol group received 1.5 mg/kg tramadol diluted in 10 ml. Isotonic saline ( 1 min. Duration) Group II: nefopam group received 0.15 mg/kg nefopam diluted in 10 ml.isotonic saline(1 min. duration) Group III: control group received isotonic saline 10 ml. (1min. duration).

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

adult patients of either sex, ASA I or II, undergoing per cutaneous nephrolithotomy(PCNL) for renal upper ureteric stone requiring catheterization of urinary bladder . This procedure usually requires postoperative bladder drainage for 12-24 hours in addition to nephrostomy .

Exclusion criteria

-Bladder outflow obstruction. -Overactive bladder( frequency > 3 times per night or mor than 8 times per 24 hours. -Epilepsy. -Myocardial ischemia or infarction , arrhythmia so, heart failure. -Renal and hepatic diseases . -Current use of mono amine oxidase inhibitors. -History of drug abuse. -Angle- closure glaucoma. -Morbid obesity( BMI> 30 kg/ m2). - History of chronic pain.

Outcome results