Effect of ketamine and haloperidol with pethidine and haloperidol for prevention of catheter-related bladder discomfort

Phase 3

• Conditions: Catheter related bladder discomfort.; Urinary catheterization as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure

• Registration Number: IRCT20171012036730N2
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 March 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 119

Inclusion Criteria

Age between 18 and 70 years
Male gender
American Society of Anesthesiologists (ASA) physical status classification I, II

Exclusion Criteria

Inability of extubating the patients after surgery
Any history of urological surgery
Patients who have any damage or distracting pain other than the site of surgery
Patients with any lesion and central nervous system disease
History of chronic pain
History of opioids or other substances consumption chronically
Benign Prostatic Hyperplasia or any urinary system obstruction
Urinary tract infection or urinary tract stone
Severe heart and liver disease or evidence of long QT segment in electrocardiography
History of overactive bladder (need to urinate more than 3 times during sleep or more than 8 times a day)
Obesity (body mass index more than 40 kilogram per square meter)
Dementia or any disorder which leads to inappropriate orientation and inability to communicate verbally
End stage renal disease (urinary volume less than 500cc per 24 hours)
Proved mental illness
Any apparent bladder dysfunction due to lumbar spinal cord stenosis
Sensitivity to phenylephrine, ketamine or pethidine
History of monoamine oxidase inhibitor (MAOI) usage in the recent two weeks

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain. Timepoint: 0, 1, 6, 24 hours after surgery. Method of measurement: Visual Analogue Scale (VAS).;Sedation. Timepoint: 0, 1, 6, 24 hours after surgery. Method of measurement: Richmond Sedation Score (RSS).;Catheter Related Bladder Discomfort severity. Timepoint: 0, 1, 6, 24 hours after surgery. Method of measurement: based on asking patients based on Likert scale.