Trial document




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  DRKS00004791

Trial Description

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Title

Sedation for CVL in children - influence of parent's voice on consumption of sedative drugs

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

To install central venous lines children usually need sedation. We want to find out if lower doses of sedative medication is needed when children vis headphones listen to their parent's voice during the intervention. Only children with indication for a central venous line can be included.

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Brief Summary in Scientific Language

Due to a lack of compliance children usually need sedation to install a CVL. Therefore propofol is often used. There exist no data if consumption of sedative agents changes if parents are present during the intervention. It was also never investigated if listening to the parent's voice alone has any influence on the demand of sedatives. Our purpose is to find out if listening to the parent's voice via headphones during installation of a central venous line has any influence on the consumption of sedative agents.

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Organizational Data

  •   DRKS00004791
  •   2013/03/05
  •   [---]*
  •   yes
  •   Approved
  •   13-5331-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   installation of central venous lines
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Interventions/Observational Groups

  •   Group 1 listening to parent's voice during intervention
  •   Group 2 wearing headphones but listening to nothing
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

amount of propofol needed in both groups

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Secondary Outcome

time until eye-opening in both groups
complications in both groups (decrease of oxygen saturation, vomiting, unintended awaken, decrease of blood pressure)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/04/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   2   Years
  •   14   Years
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Additional Inclusion Criteria

Central venous line under sedation for therapeutic or diagnostic reasons necessary

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Exclusion Criteria

no informed consent
risk of sedation without intubation (expected anatomical anomalies of airways, dyspnea without sedation)
risk of medication (intolerance, assured or suspected mitochondriopathia)
hardness of hearing

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Addresses

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Universitätsklinik Essen Klinik für Kinderheilkunde 1
    • Ms.  Dr  Eva  Tschiedel 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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    • Universitätsklinik Essen Klinik für Kinderheilkunde 1
    • Ms.  Dr  Eva  Tschiedel 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/09/14
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.