NCT00287560

Effect of a Modified Propofol Preparation on Injection Pain During Induction of Anesthesia in Children

A Comparison of Venous Tolerability and Injection Pain of a Modified Propofol Preparation and Standard Propofol in the Induction of Anesthesia in Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (planned)
• Sponsor: B. Braun Melsungen AG · Industry
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	propofol (drug)

Timeline

• Start date: 2003-08-01
• Completion: 2005-02-01
• First posted: 2006-02-07
• Last updated: 2008-02-25