Etomidate-Lipuro vs. Diprivan-Propofol with added lignocaine: incidence of injection pain in association with induction of anaesthesia in children. - E-L vs P-D

• Conditions: Any child who is to be anaesthetised for a surgical intervention on an out-patient basis. No specific diagnosis is applicable.

• Registration Number: EUCTR2004-002899-42-SE
• Lead Sponsor: Dept of Paediatric Anaesthesia, Karolinska University Hospital-Solna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br>The number of patients with painless injection in each group will be compared statistically by Fisher's exact test.