Dexamethasone as a ropivacaine adjuvant to pre-emptive incision-site infiltration analgesia in pediatric craniotomy patients: a prospective, multicenter, randomized, double-blind, controlled trial.

BACKGROUND Dexamethasone added to incision-site infiltration has been routinely used to reduce pain after tonsillectomy in children. However, this has not been studied in pediatric craniotomy patients yet. We hypothesized that incision-site infiltration with a combination of ropivacaine and dexamethasone might provide superior analgesia to ropivacaine alone in pediatric craniotomy patients. AIMS The present study aimed to evaluate the effect of locally infiltrated ropivacaine plus dexamethasone on postoperative pain after craniotomy in children. METHODS In this multicenter, double-blind, randomized, controlled trial, children aged 2-12 years, scheduled for craniotomy were prospectively enrolled at two study centers, from September 2, 2019 to July 5, 2020. Eighty children were randomly assigned (1:1) to either ropivacaine plus dexamethasone (RD) group who received pre-emptive incision-site infiltration with 0.2% ropivacaine plus 0.025% dexamethasone, or ropivacaine (R) group who received 0.2% ropivacaine alone. Primary outcome was the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS) at 24 hours postoperatively. Primary analysis was performed using the modified intention-to-treat (mITT) principle. RESULTS Pre-emptive incision-site infiltration with ropivacaine plus dexamethasone (RD group) had a reduced pain score of 2.0, compared with the pain score of 2.9 in the R group, at 24 hours postoperatively [mean difference -0.9, 95% confidence interval (CI), -1.7 to -0.2; p=0.019]. Estimated median of the time of first rescue analgesic demand was 24 hours in the RD group and 8.5 hours in the R group [hazard ratio (HR) 0.43, 95% CI 0.24 to 0.08; Log-rank p=0.0025]. No adverse events related to incision-site infiltration with dexamethasone were observed in this study. CONCLUSIONS The addition of dexamethasone to ropivacaine for preoperative incision-site infiltration has better postoperative analgesic effect than ropivacaine alone in pediatric craniotomy patients.