Patient safety of adjunct pre-operative intravenous S-ketamine for pain relief in third molar surgery - a randomised, placebo-controlled, double-blind trial.
British journal of pain – June 20, 2024
Source: PubMed
Summary
S-ketamine shows promise as a safe pain relief option for dental surgery, with minimal physiological effects when properly administered. In this groundbreaking trial, 168 patients receiving wisdom tooth removal were given either S-ketamine or a placebo. While high-dose patients showed brief changes in oxygen levels, no serious adverse events occurred. The medication proved safe and effective when combined with standard sedation, offering a valuable option for surgical pain management.
Abstract
To study patient safety in third molar surgery, where two different doses of S-ketamine were administered for pain relief and compared to a placebo (saline). The primary focus was capillary oxygen saturation of the blood (SpO2) and secondarily, alterations in respiratory rate, blood pressure, pulse or adverse events. One hundred and sixty-eight subjects were included in a randomised, placebo-controlled, double-blind trial. The two subanaesthetic study drugs were low-dose S-ketamine (0.125 mg/kg) and high-dose S-ketamine (0.25 mg/kg). Every patient was sedated with midazolam prior to infusion of the investigational drug. The teeth were surgically removed according to a routine clinical procedure, under local anaesthesia. Primary end-point for the safety aspects was capillary oxygen saturation (SpO2) after administration of the investigational drug was finished. A significant difference was found between the placebo and the high-dose group at that point (p = .021), with a decrease of saturation in the high-dose group. The lowest saturation and the number of registrations of SpO2 <90% did not show any difference between groups. Oxygen supplementation was given in circa 40% of the cases with no differences between the intervention groups. No other significant differences between groups regarding saturation or respiratory rate were noted. In this study, it was safe to use adjunct preoperative single-dose intravenous S-ketamine 0.25 mg/kg body weight for pain relief, in midazolam-sedated patients receiving third molar surgery. There were no serious adverse events or symptoms of overdose nor any clinically relevant effects on circulatory or respiratory parameters.