Diprospan as an adjuvant to ropivacaine for incision site infiltration analgesia in pediatric craniotomy patients: a prospective, multicentre, randomized, evaluator-blind, controlled trial
Bibliographic record
Abstract
BACKGROUND: The administration of local anesthetics directly into the surgical incision is an effective method for alleviating postoperative pain; however, its duration of analgesia is often limited. Diprospan is a dual-action formulation that combines the rapid onset of betamethasone sodium phosphate with the prolonged effects of betamethasone dipropionate. When used as an adjuvant to ropivacaine for pre-incisional local infiltration anesthesia, diprospan has demonstrated significant analgesic efficacy in adult craniotomy patients. However, its effectiveness in pediatric craniotomy patients remains uncertain. METHODS: This prospective, multicentre, evaluator-blinded randomised controlled trial enrolled children aged 2 to 12 years who were scheduled for craniotomy between 10 July 2024 and 7 November 2024 at two study centres. A total of 108 eligible participants were randomly assigned in a 1:1 ratio to either the diprospan group, receiving 0.012% diprospan combined with 0.5% ropivacaine for local infiltration anesthesia, or the control group, receiving 0.5% ropivacaine alone. The primary outcome was the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS) score at 24 hours postoperatively. The primary analysis followed the modified intention-to-treat (mITT) principle. All parametric data are presented as mean ± SD; non-normally distributed variables are reported as median [interquartile range]. RESULTS: There were no significant differences in baseline characteristics between the two groups (P > 0.05). The mCHEOPS score at 24 h postoperatively was significantly lower in the diprospan group than in the control group (0.3 ± 0.5 in the diprospan group; 3.4 ± 1.1 in the control group, p<0.001). Diprospan reduced rescue analgesia (P<0.001), prolonged analgesia duration (18.2 vs 10.3 h), and showed no safety concerns versus controls. PONV, length of hospital stay, and wound healing were comparable, supporting its use for pediatric craniotomy pain management. CONCLUSIONS: Diprospan and ropivacaine infiltration can provide satisfactory postoperative pain relief after craniotomy in children and is a straightforward, simple and safe technique worthy of clinical dissemination.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".