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Comparison of intravenous tramadol and ketamine for prevention of catheter-related bladder discomfort after laparoscopic surgery

Comparison of intravenous tramadol and ketamine for prevention of catheter-related bladder discomfort after laparoscopic surgery: A randomized, placebo-controlled, double-blind study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20140220001
Enrollment
210
Registered
2014-02-20
Start date
2014-04-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

catheter&#45

Interventions

tramadol 1.5 mg/kg diluted with normal saline solution into 5 ml intravenous before urinary catheterization,ketamine 0.5 mg/kg diluted with normal saline solution into 5 ml intravenous before urinary
tramadol,ketamine,placebo

Sponsors

Chulalongkorn University
Lead Sponsor
Department of Anesthesiology&#44
Collaborator
Faculty of Medicine&#44
Collaborator
Chulalongkorn University
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: adult patients aged 18-70 years old with American Society of Anesthesiologists physical status I and II undergoing elective laparoscopic surgery at King Chulalongkorn Memorial Hospital

Exclusion criteria

Exclusion criteria: patients requiring postoperative ICU admission and respiratory support history of chronic pain or chronic analgesic usage or chemical substance abuse history of overactive bladder (OAB) defined as urination frequency more than 3 times at night or 8 times during a 24-hour period history of bladder outlet obstruction or benign prostatic hypertrophy disturbance of the central nervous system severe cardivascular or hepatic disease end stage renal disease (urine output less than 500 ml/24 hour morbid obesity (BMI >=35) hypersensitivity to tramadol or ketamine patients who are unable to communicate patients with difficulty in urinary catheterization duration of surgery longer than 4 hours conversion to laparotomy pregnancy

Design outcomes

Primary

MeasureTime frame
Catheter related bladder discomfort at 0, 1, 2, 6 and 24 hour after admitting to post-anesthetic care unit visual analogue scale

Secondary

MeasureTime frame
side effects of study drugs at 0, 1, 2, 6 and 24 hour after admitting to post-anesthetic care unit 4 point rating scale,post-operative pain score at 0, 1, 2, 6 and 24 hour after admitting to post-anesthetic care unit visual analogue scale

Countries

Thailand

Contacts

Public ContactRattanaporn Burimsittichai

Department of Anesthesiology, Faculty of Medicine, Chulalongkorn University

rburimsittichai@yahoo.com+662 256 4295

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026