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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00287560
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : February 25, 2008
Information provided by:
B. Braun Melsungen AG

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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: propofol (drug) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Comparison of Venous Tolerability and Injection Pain of a Modified Propofol Preparation and Standard Propofol in the Induction of Anesthesia in Children
Study Start Date : August 2003
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Primary Outcome Measures :
  1. incidence of spontaneous expression of pain during injection

Secondary Outcome Measures :
  1. anesthetists VAS for assessment of injection pain, propofol dosage and requirements, hemodynamic parameters, safety laboratory, adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00287560

Sponsors and Collaborators
B. Braun Melsungen AG
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Principal Investigator: Gerd P Molter, MD, PhD Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH
Layout table for additonal information Identifier: NCT00287560    
Other Study ID Numbers: BBMDE-0312
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: February 25, 2008
Last Verified: February 2008
Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General