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