Effect of a Modified Propofol Preparation on Injection Pain During Induction of Anesthesia in Children - Full Text View

Sponsored by:	B. Braun Melsungen AG
Information provided by:	B. Braun Melsungen AG
ClinicalTrials.gov Identifier:	NCT00287560

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 III

MedlinePlus related topics: Anesthesia

Drug Information available for: Propofol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
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

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

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

Study placed in the following topic categories:

Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Central Nervous System Depressants

Anesthetics
Pain
Propofol

Additional relevant MeSH terms:

Anesthetics, Intravenous
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Physiological Effects of Drugs

Central Nervous System Depressants
Anesthetics
Propofol
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009