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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
History of Changes
  Purpose

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 Intervention Phase
Anesthesia
 Drug: propofol (drug)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Drug Information available for: Propofol
U.S. FDA Resources

Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:
  • incidence of spontaneous expression of pain during injection

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

Estimated Enrollment: 64
Study Start Date: August 2003
Estimated Study Completion Date: February 2005
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.

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287560

Sponsors and Collaborators
B. Braun Melsungen AG
Investigators
Principal Investigator: Gerd P Molter, MD, PhD Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00287560     History of Changes
Other Study ID Numbers: BBMDE-0312
Study First Received: February 6, 2006
Last Updated: February 22, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Anesthetics
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 22, 2013