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

A Comparison of Venous Tolerability and Injection Pain of a Modified Propofol Preparation and Standard Propofol in the 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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: propofol (drug)

Detailed 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.

• Study Type: Interventional
• Enrollment: 64
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
incidence of spontaneous expression of pain during injection

Secondary Outcome Measures

Outcome Measure
anesthetists VAS for assessment of injection pain, propofol dosage and requirements, hemodynamic parameters, safety laboratory, adverse events

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Investigators: Principal Investigator: Gerd P Molter, MD, PhD, Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Study Completion: February 1, 2005

Study Registration Dates

• First Submitted: February 6, 2006
• First Submitted That Met QC Criteria: February 6, 2006
• First Posted (Estimate): February 7, 2006

Study Record Updates

• Last Update Posted (Estimate): February 25, 2008
• Last Update Submitted That Met QC Criteria: February 22, 2008
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: BBMDE-0312