Effect of a Modified Propofol Preparation on Injection Pain During Induction of Anesthesia in Children

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287560
• Other study ID #: BBMDE-0312
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2006
• Last updated: February 22, 2008
• Start date: August 2003
• Est. completion date: February 2005

Study information

• Verified date: February 2008
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• propofol (drug)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of spontaneous expression of pain during injection
Secondary	anesthetists VAS for assessment of injection pain, propofol dosage and requirements, hemodynamic parameters, safety laboratory, adverse events