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

This study has been completed.
Sponsor:
Information provided by:
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT00287560
First received: February 6, 2006
Last updated: February 22, 2008
Last verified: February 2008

February 6, 2006
February 22, 2008
August 2003
Not Provided
incidence of spontaneous expression of pain during injection
Same as current
Complete list of historical versions of study NCT00287560 on ClinicalTrials.gov Archive Site
anesthetists VAS for assessment of injection pain, propofol dosage and requirements, hemodynamic parameters, safety laboratory, adverse events
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Anesthesia
Drug: propofol (drug)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
February 2005
Not Provided

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
Both
2 Years to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00287560
BBMDE-0312
Not Provided
Not Provided
B. Braun Melsungen AG
Not Provided
Principal Investigator: Gerd P Molter, MD, PhD Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH
B. Braun Melsungen AG
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP