1. Patient safety of adjunct pre-operative intravenous S-ketamine for pain relief in third molar surgery – a randomised, placebo-controlled, double-blind trial.
- Author
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Eriksson, Lars B, Gordh, Torsten, Karlsten, Rolf, Thor, Andreas, and Tegelberg, Åke
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THIRD molar surgery , *OXYGEN saturation , *CAPILLARIES , *PATIENT safety , *KETAMINE , *RESEARCH funding , *LOCAL anesthesia , *INFRARED radiation in medicine , *POSTOPERATIVE pain , *BLIND experiment , *STATISTICAL sampling , *INVESTIGATIONAL drugs , *BODY weight , *VISUAL analog scale , *FISHER exact test , *PREOPERATIVE care , *RANDOMIZED controlled trials , *MANN Whitney U Test , *DESCRIPTIVE statistics , *INTRAVENOUS therapy , *PAIN management , *RESPIRATORY measurements , *BLOOD pressure , *ADVERSE health care events , *LIDOCAINE - Abstract
Purpose: 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. Methods: 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. Results: 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. Conclusion: 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. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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