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.

Abstract

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. 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). 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. NCT06860711.