BACKGROUND:Pain on injection is a major disadvantage of propofol, experienced by the vast majority of patients. Since the traditional formulation has almost normal osmolality and pH, it is hypothesised that the concentration of free propofol in the aqueous phase of the emulsion is responsible for the pain and that reducing the amount of free propofol would also reduce the frequency and intensity of pain on injection. This study was designed to investigate whether pain on injection can be reduced in frequency and intensity by a new formulation of propofol. METHODS: We performed a monocentre, controlled, randomised, double-blind study to compare the pain produced by intravenous injection of a new propofol preparation (propofol-MCT/LCT) with standard propofol in patients undergoing elective surgical procedures. A total of 184 non-premedicated patients received either1% propofol prepared in a mixture of medium and long chain triglycerides (Propofol-MCT/LCT, Propofol- Lipuro, B. Braum Melsungen AG) or standard 1% propofol prepared exclusively in long chain triglycerides (Propofol-LCT; Disoprivan, AstraZeneca) into a vein of the dorsal hand for induction of anaesthesia. Anaesthesia was maintained by TIVA with propofol and remifentanil. Pain on injection was recorded and graded as none, mild, moderate or severe. RESULTS: Patients receiving propofol-MCT/LCT had a significantly lower incidence of pain on injection compared to the standard propofol group (37% vs 64%) with the intensity of pain also being less severe. There were no differences between both groups in propofol dosage for induction (3.2 +/- 0.8 mg/kg vs 3.3 +/- 0.9 mg/kg) and maintenance of anaesthesia (3.4 +/- 0.6 mg/kg/h vs 3.2 +/- 0.5 mg/kg/h), remifentanil dosage (25 +/- 6 micrograms/kg/h vs. 24 +/- 6 micrograms/kg/h), intraoperative hemodynamics, recovery parameters and postoperative patient satisfaction. Postoperative thrombophlebitis at the injection site for propofol was not observed in any of the patients. CONCLUSIONS:Propofol-MCT/LCT produced significantly less pain on injection when compared to standard propofol in ASA I and II patients undergoing elective surgery. Pain was also significantly less severe, with both effects presumably being due to the lower concentration of free propofol in the MCT/LCT-preparation. With regard to injection pain propofol-MCT/LCT offers significant a advantage over standard propofol.
RCT Entities:
BACKGROUND:Pain on injection is a major disadvantage of propofol, experienced by the vast majority of patients. Since the traditional formulation has almost normal osmolality and pH, it is hypothesised that the concentration of free propofol in the aqueous phase of the emulsion is responsible for the pain and that reducing the amount of free propofol would also reduce the frequency and intensity of pain on injection. This study was designed to investigate whether pain on injection can be reduced in frequency and intensity by a new formulation of propofol. METHODS: We performed a monocentre, controlled, randomised, double-blind study to compare the pain produced by intravenous injection of a new propofol preparation (propofol-MCT/LCT) with standard propofol in patients undergoing elective surgical procedures. A total of 184 non-premedicated patients received either 1% propofol prepared in a mixture of medium and long chain triglycerides (Propofol-MCT/LCT, Propofol- Lipuro, B. Braum Melsungen AG) or standard 1% propofol prepared exclusively in long chain triglycerides (Propofol-LCT; Disoprivan, AstraZeneca) into a vein of the dorsal hand for induction of anaesthesia. Anaesthesia was maintained by TIVA with propofol and remifentanil. Pain on injection was recorded and graded as none, mild, moderate or severe. RESULTS:Patients receiving propofol-MCT/LCT had a significantly lower incidence of pain on injection compared to the standard propofol group (37% vs 64%) with the intensity of pain also being less severe. There were no differences between both groups in propofol dosage for induction (3.2 +/- 0.8 mg/kg vs 3.3 +/- 0.9 mg/kg) and maintenance of anaesthesia (3.4 +/- 0.6 mg/kg/h vs 3.2 +/- 0.5 mg/kg/h), remifentanil dosage (25 +/- 6 micrograms/kg/h vs. 24 +/- 6 micrograms/kg/h), intraoperative hemodynamics, recovery parameters and postoperative patient satisfaction. Postoperative thrombophlebitis at the injection site for propofol was not observed in any of the patients. CONCLUSIONS:Propofol-MCT/LCT produced significantly less pain on injection when compared to standard propofol in ASA I and II patients undergoing elective surgery. Pain was also significantly less severe, with both effects presumably being due to the lower concentration of free propofol in the MCT/LCT-preparation. With regard to injection painpropofol-MCT/LCT offers significant a advantage over standard propofol.