NCT00287560

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
Last Updated

February 25, 2008

Status Verified

February 1, 2008

First QC Date

February 6, 2006

Last Update Submit

February 22, 2008

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • incidence of spontaneous expression of pain during injection

Secondary Outcomes (1)

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

Interventions

propofol (drug)DRUG

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

PropofolPharmaceutical Preparations

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Gerd P Molter, MD, PhD

    Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 7, 2006

Study Start

August 1, 2003

Study Completion

February 1, 2005

Last Updated

February 25, 2008

Record last verified: 2008-02