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

NCT ID: NCT00287560

Last Updated: 2008-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2005-02-28

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

propofol (drug)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: lead

Principal Investigators

Gerd P Molter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH

Other Identifiers

BBMDE-0312

Identifier Type: -

Identifier Source: org_study_id