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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00287560

Enrollment

Registered

2006-02-07

Start date

2003-08-31

Completion date

2005-02-28

Last updated

2008-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief 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.

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.

Interventions

DRUGpropofol (drug)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

2 Years to 6 Years

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

Design outcomes

Primary

Measure	Time frame
incidence of spontaneous expression of pain during injection	—

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026