Pain, Postoperative Kidney Calculi Percutaneous Nephrolithotomy Paracetamol Acetaminophen Postoperative Pain Oral Administration Intravenous Administration Analgesia Randomized Controlled Trial
Conditions
Interventions
Participants received 1 g of intravenous paracetamol diluted in 100 mL solution. The intervention was administered 30 minutes after completion of percutaneous nephrolithotomy and every 8 hours thereaf
Active Comparator Drug,Active Comparator Drug
Intravenous Paracetamol,Oral Paracetamol
Sponsors
This study received no external funding. The study was funded by the authors.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older 2. Scheduled to undergo percutaneous nephrolithotomy 3. American Society of Anesthesiologists physical status classification I or II 4. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Active or inadequately controlled urinary tract infection 2. Pregnancy 3. Suspected malignancy involving the kidney or anticipated access tract 4. Bleeding disorder 5. Substance abuse 6. Known hypersensitivity to paracetamol or ketorolac 7. Hepatic dysfunction, defined as serum transaminase levels greater than twice the upper limit of normal 8. Impaired renal function, defined as serum creatinine greater than 1.5 mg/dL 9. Current use of monoamine oxidase inhibitors or discontinuation within the previous two weeks 10. Medical or psychiatric conditions limiting reliable communication 11. Pre-existing pain-related or neurologic conditions that could interfere with postoperative 12. Numeric Rating Scale assessment, including neuropathy or diabetes mellitus 13. Use of nonsteroidal anti-inflammatory drugs or other analgesic medications within 12 hours before study drug administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean postoperative pain score 0 to 24 hours after surgery Mean Numeric Rating Scale pain score during the first 24 hours after percutaneous nephrolithotomy | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain score 1, 4, 8, 12, 16, 20, and 24 hours after surgery Numeric Rating Scale pain score measured at 1, 4, 8, 12, 16, 20, and 24 hours after percutaneous nephrolithotomy,Peak pain score 0 to 24 hours after surgery Highest Numeric Rating Scale pain score recorded during the first 24 hours after percutaneous nephrolithotomy,Rescue analgesia requirement 0 to 24 hours after surgery Requirement for intravenous ketorolac rescue analgesia during the first 24 postoperative hours,Postoperative fever Postoperative day 1 Presence of postoperative fever recorded after percutaneous nephrolithotomy,Hemoglobin drop Postoperative day 1 Difference between preoperative and postoperative hemoglobin levels,Postoperative leukocyte count Postoperative day 1 Leukocyte count measured from postoperative laboratory assessment,Operative duration Intraoperative Duration of percutaneous nephrolithotomy procedure in minutes,Stone-free status Intraoperative Operator-assessed stone-free status after stone removal | — |
Countries
Indonesia
Contacts
Public ContactDaniel Amartya
Department of Urology University of Indonesia Hospital
Outcome results
None listed