Any child who is to be anaesthetised for a surgical intervention on an out-patient basis. No specific diagnosis is applicable.
Conditions
Interventions
Trade Name: Etomidate-Lipuro
Pharmaceutical Form:
Concentration unit: mg/ml milligram(s)/millilitre
Concentration number: 2-
Trade Name: Diprivan
Pharmaceutical Form:
Concentration unit: mg/ml mill
Sponsors
Dept of Paediatric Anaesthesia, Karolinska University Hospital-Solna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 6 months-15 years 2. Sheduled for anaesthesia for an out-patient surgical intervention. 3. Healthy except for the reason for surgery = ASA class 1 or 2. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Age < 6 months 2. Not scheduled for out-patient surgery. 3. Known hypersensitivity for soya-bean oil or fat emulsions. 4. Symptomatic disease other than the reason for surgery = ASA 3 or 4. 5. Known hypersensitivity for local anaesthetics. 6. Known history of porphyria. 7. Known dysfunction of the adrenal cortex
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The rate of injection pain of propofol is unacceptably high in children despite attempts to reduce this by concomittant mixing with a small dose of lignocaine (0.2-0.3 mg kg-1). Injection pain of Etomidate-Lipuro in adults has been reported to be rare. Thus, the main objective of this CT is to compare the rate of injection pain between Etomidate-Lipuro and Diprivan-Propofol mixed with lignocaine during anaesthesia induction in children undergoing out-patient surgery.;Secondary Objective: There are no secondary objectives in this trial.;Primary end point(s): Occurence of injection pain following bolus injection of the study drug for induction of anaesthesia. Pain is assessed by a train anaesthetic nurse in the same way as in a previous trial by our group as: no, slight, moderate or severe pain. The number of patients with painless injection in each group will be compared statistically by Fisher's exact test. | — |
Countries
Sweden
Outcome results
None listed