Peer-reviewed article
Safety of short-term non-steroidal anti-inflammatory drug use in the postoperative setting in paediatric patients with chronic kidney disease: protocol for a randomised, placebo-controlled trial.
Xiang AH, Hwang CK, Clennon E, To T, Pyrzanowski J et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This document is a protocol for a randomised controlled trial about the safety of pain-relief medications (NSAIDs) in children with chronic kidney disease undergoing surgery. It describes the planned study design, participants, and outcomes but does not report actual results or findings from implemented research. The trial has not yet been completed and no evidence of effectiveness is presented.
Key points
- The study will test whether short-term NSAID use causes kidney injury in children with mild-to-moderate chronic kidney disease after urological surgery
- The trial is randomised, placebo-controlled, and will include 164 children aged over 18 months at two US academic hospitals
- Primary outcome is acute kidney injury measured by kidney function markers and urine output
- Secondary outcomes include postoperative pain scores and opioid medication use
- The protocol has ethical approval and is registered (NCT06860711)
Limitations
This is a protocol document only, describing a planned trial. It contains no results, no data on whether the intervention works, and no evidence of effectiveness because the research has not yet been conducted or reported.
Abstract
Introduction Non-steroidal anti-inflammatory drugs (NSAIDs) are a key component of multimodal analgesia in paediatric surgical care but are often avoided in patients with chronic kidney disease (CKD) due to concerns for nephrotoxicity. This trial aims to evaluate the safety of short-term NSAID use in paediatric patients with mild-to-moderate CKD undergoing inpatient urological surgery. Methods and analysis This is a multicentre, double-blinded, randomised, placebo-controlled trial evaluating short-term NSAID use in paediatric patients with CKD stages 2-3a after urological surgeries requiring admission. This study is being conducted at two academic paediatric urology departments in the USA. Patients aged >18 months will be randomised 1:1 to receive ketorolac/ibuprofen or placebo for ≤5 days postoperatively. The primary outcome is acute kidney injury (AKI) as defined according to Kidney Disease: Improving Global Outcomes criteria based on serum creatinine trends and urine output. Secondary outcomes are postoperative pain scores and opioid use (reported as morphine equivalents/kg/day). Fisher's exact test will compare AKI rates between groups. The recruitment goal of 164 participants provides 80% power to detect a 20% absolute increase in AKI incidence (baseline AKI rate of 15% based on prior studies, two-sided testing). Ethics and dissemination This study has been approved by the Colorado Multiple Institutional Review Board (COMIRB #24-1252) and will be conducted in accordance with institutional ethical guidelines. Written informed consent will be obtained from a parent or legal guardian for all participants, and child assent will be obtained when developmentally appropriate and required by institutional policy. Study findings will be disseminated through presentation at scientific meetings and publications in peer-reviewed journals. Trial registration number NCT06860711.