Intraoperative Glycaemia Following Paracetamol with and without Glucose: A Randomized-Controlled Trial

Background: Hyperglycaemia is conversely a risk factor for perioperative complications. We are currently using a generic 3.3 g glucose containing formula of intravenous 1000 mg paracetamol for perioperative analgesia. Our main goal was to compare the trends of glycaemic values after administration of a generic 3.3 g glucose containing formula with a non-glucose containing branded formula of intravenous 1000 mg paracetamol. Methods: A exploratory proof-of-concept randomized clinical trial was conducted with 150 patients scheduled for elective gynaecologic. Patients were randomly assigned into three groups: control group (saline); active-control group: intraoperative administration of a branded non-glucose containing 1000 mg paracetamol formula; experimental group: intraoperative administration of a generic 3.3 g glucose containing 1000 mg paracetamol formula. The primary outcome was mean change from baseline in glaucoma. In case significant differences were found, the following secondary outcomes were explored: the proportion of patients with high glycaemia values (>150 mg/dL) and the proportion of patients with negative glycaemic variation. Results: Mean glycaemia change was higher after generic 3.3 g glucose containing paracetamol formula both in comparison to placebo (16.3 mg/dL [95% CI: 6.1 to 26.6]) and active-control (19.1 mg/dL [8.2 to 30.0] groups. Similar results were found in the intention-to-treat analysis. In only the experimental group, patients had high glycaemic values (11.3%). Conclusions: This study showed that in non-diabetic, under non-cardiac surgery, administration of a generic glucose-containing formula of intravenous 1000 mg paracetamol was associated with poorer glycaemic control. These results raise the question of a possible increased risk among these patients. Further studies using diabetic patients are recommended.