ClinicalTrials.Veeva

Menu

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

B. Braun logo

B. Braun

Status and phase

Completed
Phase 3

Conditions

Anesthesia

Treatments

Drug: propofol (drug)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00287560
BBMDE-0312

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

2 to 6 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems