Effect of a Modified Propofol Preparation on Injection Pain During Induction of Anesthesia in Children
The purpose of the study is to determine wether a modified propofol preparation shows any effect on the incidence of injection pain in children undergoing elective surgery under general anesthesia.
Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||A Comparison of Venous Tolerability and Injection Pain of a Modified Propofol Preparation and Standard Propofol in the Induction of Anesthesia in Children|
- incidence of spontaneous expression of pain during injection
- anesthetists VAS for assessment of injection pain, propofol dosage and requirements, hemodynamic parameters, safety laboratory, adverse events
|Study Start Date:||August 2003|
|Estimated Study Completion Date:||February 2005|
Pain on injection is the most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287560
|Principal Investigator:||Gerd P Molter, MD, PhD||Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH|