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.

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 group who received pre-emptive incision-site infiltration with 0.2% ropivacaine plus 0.025% dexamethasone, or ropivacaine group who received 0.2% ropivacaine alone. Primary outcome was the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS) at 24 h postoperatively. Primary analysis was performed using the modified intention-to-treat principle.

Results: Pre-emptive incision-site infiltration with ropivacaine plus dexamethasone had a reduced pain score of 2.0, compared with the pain score of 2.9 in the ropivacaine group, at 24 h postoperatively (mean difference -0.9, 95% confidence interval [CI], -1.7 to -0.2; p = .019). Estimated median of the time of first rescue analgesic demand was 24 h in the ropivacaine plus dexamethasone group and 8.5 h in the ropivacaine group [hazard ratio 0.43, 95% CI 0.24 to 0.08; Log-rank p = .0025]. No adverse events related to incision-site infiltration with dexamethasone were observed in this study. Discussion: Dexamethsone reduces the local production of pro-inflammatory factors after tissue damage and as a ropivacaine adjuvant for incision-site infiltration reduced the pain scores by 31% at 24 h postoperatively. The results were similar to several prior studies on to tonsillectomy patients. However, this changes on pain scores might has limited clinical significance.

Conclusions: The addition of dexamethasone to ropivacaine for preoperative incision-site infiltration has better postoperative analgesic effect than ropivacaine alone in pediatric craniotomy patients.