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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol (drug) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of spontaneous expression of pain during injection |
| Measure | Description | Time Frame |
|---|---|---|
| anesthetists VAS for assessment of injection pain, propofol dosage and requirements, hemodynamic parameters, safety laboratory, adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerd P Molter, MD, PhD | Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH | Principal Investigator |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |