Y Nyman1, K von Hofsten, A Georgiadi, S Eksborg, P A Lönnqvist. 1. Department of Paediatric Anaesthesia and Intensive Care, Astrid Lindgrens Children's Hospital, Karolinska Institutet, Stockholm, Sweden. yvonne.nyman@karolinska.se
Abstract
BACKGROUND: The incidence of pain on injection of propofol remains unacceptably high in children, despite various strategies to reduce it. A new drug formulation of propofol has, in adult studies, been reported to cause less injection pain compared with other propofol solutions. The aim of the present prospective randomized double-blind clinical trial was to compare the incidence of pain-free injection following the use of this new formulation with that following the use of propofol with added lidocaine in children undergoing day case surgery. METHODS:Eighty-three children (age range 2-18 yr) were randomized to receive 3 mg kg(-1) of either Propofol-Lipuro (propofol dissolved in a mixture of medium- and long-chain triglycerides [MCT-LCT]; group pL, n=42) or Diprivan (propofol dissolved in long-chain triglycerides [LCT]) with added lidocaine (0.3 mg kg(-1)) (group pD, n=41). A specially trained nurse anaesthetist assessed the occurrence of injection pain using a four-graded pain scale. RESULTS: Significantly fewer patients had an entirely pain-free propofol injection in group pL (33.3%) than in group pD (61.0%) (P=0.016). CONCLUSIONS: A new MCT-LCT propofol formulation as a plain solution was associated with a higher incidence of injection pain than LCT propofol with added lidocaine when used for induction of anaesthesia in children.
RCT Entities:
BACKGROUND: The incidence of pain on injection of propofol remains unacceptably high in children, despite various strategies to reduce it. A new drug formulation of propofol has, in adult studies, been reported to cause less injection pain compared with other propofol solutions. The aim of the present prospective randomized double-blind clinical trial was to compare the incidence of pain-free injection following the use of this new formulation with that following the use of propofol with added lidocaine in children undergoing day case surgery. METHODS: Eighty-three children (age range 2-18 yr) were randomized to receive 3 mg kg(-1) of either Propofol-Lipuro (propofol dissolved in a mixture of medium- and long-chain triglycerides [MCT-LCT]; group pL, n=42) or Diprivan (propofol dissolved in long-chain triglycerides [LCT]) with added lidocaine (0.3 mg kg(-1)) (group pD, n=41). A specially trained nurse anaesthetist assessed the occurrence of injection pain using a four-graded pain scale. RESULTS: Significantly fewer patients had an entirely pain-free propofol injection in group pL (33.3%) than in group pD (61.0%) (P=0.016). CONCLUSIONS: A new MCT-LCTpropofol formulation as a plain solution was associated with a higher incidence of injection pain than LCTpropofol with added lidocaine when used for induction of anaesthesia in children.