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

Abstract

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 incisionsite infiltration has better postoperative analgesic effect than ropivacaine alone in pediatric craniotomy patients.

Effect of scalp nerve block with ropivacaine on postoperative pain in pediatric patients undergoing craniotomy: A randomized controlled trial

“…Another advantage of combining SNB with general anesthesia in pediatric craniotomy patients has the potential for decreasing intraoperative general anesthetic requirements. Pediatric neurosurgery usually takes a long time, so it requires a lot of general anesthetics in the absence of regional anesthesia ( 9 , 10 ). However, the neurotoxicity of general anesthetics have been well-documented in some animal models and clinical trials ( 28 – 30 ).…”

“…The sample size was calculated based on data available in published studies and our clinical experience at the study centers using the G * Power software (version 3.1.9.2, Franz Faul, Kiel University, Germany) ( 9 , 10 ). According to previous studies, the incidence of moderate postoperative pain in children is ~50% in pediatric craniotomy patients ( 10 ).…”

“…The sample size was calculated based on data available in published studies and our clinical experience at the study centers using the G * Power software (version 3.1.9.2, Franz Faul, Kiel University, Germany) ( 9 , 10 ). According to previous studies, the incidence of moderate postoperative pain in children is ~50% in pediatric craniotomy patients ( 10 ). Assuming a two-sided α value of 0.05 and a β value of 0.2, we estimated that 21 patients in each group would be required to detect a 1.8-point difference in the FLACC score.…”

“…Sixty pediatric patients aged 2-12 years with American Society of Anesthesiologists (ASA) physical status I or II scheduled to undergo elective supratentorial brain tumor surgery and to receive general anesthesia were prospectively screened for possible inclusion. The exclusion criteria included: (1) Pediatric patients aged>12 or <2 years; (2) Children with mental disorders; (3) Children whose authorized surrogates are unwilling to participate in the study; (4) Children with severe diseases or cardiac insufficiency; (5) Emergency craniotomies; (6) Children with severe kidney or liver diseases; (7) Children with severe coagulation disorders; (8) Children who cannot be weaned from endotracheal intubation following surgery; (9) Children with a history of allergy to opioids or other anesthetics; (10) Children with a history of analgesic substance abuse.…”

“…Inadequate postoperative pain control in children following craniotomy may cause severe consequences such as agitation, intracranial hypertension, and postoperative hemorrhage, which may increase morbidity and mortality ( 9 , 10 ). Given the side effects of opioids, it is necessary to minimize reliance on opioid analgesia in craniotomy patients.…”