Status:
COMPLETED
Effect of a Modified Propofol Preparation on Injection Pain During Induction of Anesthesia in Children
Lead Sponsor:
B. Braun Melsungen AG
Conditions:
Anesthesia
Eligibility:
All Genders
2-6 years
Phase:
PHASE3
Brief 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. S...
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. ad...
Eligibility Criteria
Inclusion
- age \>= 2 and \< 6 years
- written informed consent of the parents
- anesthetic risc classified as ASA I - III
- patient undergoing elective surgery under general anesthesia
- venous access for induction of anesthesia on the dorsum of the hand
- hospital care for at least 3 hrs after end of anesthesia guaranteed
Exclusion
- intolerability of the drugs tested
- current drug medication with sedative effect
- patient is expected to require concomitant medication not allowed in the study
- history of or current renal or hepatic disease, cardiac insufficiency
- hypovolemia
- increased cranial pressure
- simultaneous participation in another clinical trial or participation during the month preceding this study
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00287560
Start Date
August 1 2003
End Date
February 1 2005
Last Update
February 25 2008
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