Overview

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

Status:
Completed
Trial end date:
2005-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
B. Braun Melsungen AG
Treatments:
Propofol
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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