NCT Number: NCT00287560
Effect of a Modified Propofol Preparation on Injection Pain During 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.
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Conditions
Age range
2 year–6 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
incidence of spontaneous expression of pain during injection
Secondary outcomes
-
anesthetists VAS for assessment of injection pain, propofol dosage and requirements, hemodynamic parameters, safety laboratory, adverse events
Sponsors and collaborators
Lead sponsor
B. Braun Melsungen AG
Industry
Registry information
Official study title
A Comparison of Venous Tolerability and Injection Pain of a Modified Propofol Preparation and Standard Propofol in the Induction of Anesthesia in Children
Important dates
- Study start
- 2003
- Study completion
- 2005
- First posted
- Feb 7, 2006
- Registry last updated
- Feb 25, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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