Trial document




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  DRKS00000502

Trial Description

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Title

Evaluation of a ruler to find weigth-adapted dosings of medications in pediatric emergency care - non-randomised pre-post-design with a historical controll-group.

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Trial Acronym

[---]*

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URL of the Trial

http://www.notfalllineal.de

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Brief Summary in Lay Language

Emergency physicians all over the world perform resuscitations with a rate of success compared to adults that is smaller than it should be, because of the better circumstances concerning organ functions in children. This is primarily caused by a lack of experiences and knowledge. The major problem is well known as errors of medication next to problems with the pediatric airway, whereas 10-fold medication-errors occur 3 times as frequently as in adults and are life-threatening. The “Pädiatrisches Notfalllineal” is a ruler that offers a length-based weight estimation and contains additionally drug-dose and equipment-size recommendations and physiological reference-values. It has been proven, that the length-based method of weight-estimation is the more accurate than age-based estimation rules. There is a comparable device, known as “Broselow-tape” and used in the US since middle of the 80´s, which has already been evaluated. The aim of this study is to evaluate this newer ruler.

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Brief Summary in Scientific Language

Preclinical emergency situations in children require a drug treatment more sophisticated and related on body weight, as it does in adults. In addition, due to the reduced number of life-threatening events in children, the chance to gain practice experience with this is much lower. It is possible that the weight of the child at the time of supply is not known to the treating doctor.
Because of these problems, we have developed a tool for estimating childrens body weight by length measurement which additionally shows weight-related dose an equipment-size recommendations (using the "Pediatric Emergency ruler"). An technically identical system was developed independently to our tape in the U.S. many years ago. It is known under the name Broselow tape and frequently evaluated. In actual medical literature it is classified as essential for all emergency facilities, which have to deal with children's emergencies. Because of a patent rejected in Europe, it is not sold here.
The present investigation is to demonstrate the value of our system using a non-randomized pre-post study with historical controls. In addition, we want to do a survey on the acceptance of the system among emergency physicians. All patient data will be analyzed and published anonymously.
We expect a more individualized drug therapy, as was shown with the comparable system in the U.S. already. The treatment of the patient will be performed as necessary to the patient, the investigation does not changed or enhanced invasive procedures. Thus, there certainly isn’t an increased risk for a transient or permanent injury because of the treated emergency case.
By scientifically verifying the benefit of our pediatric emergency ruler, we want to contribute to its rapid spread and acceptance. We like to achieve a contribution to improving the care of children in emergency situations.

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Organizational Data

  •   DRKS00000502
  •   2010/07/29
  •   [---]*
  •   yes
  •   Approved
  •   08-161, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   I46.0 -  Cardiac arrest with successful resuscitation
  •   Life threatening events.
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Interventions/Observational Groups

  •   Historical control group.
  •   Prospective observational group.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Other
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

Correct bodyweight-relates doses of emergency medications, assessed as deviation of means and variations, as well as incidence of surely clinical relevant wrong doses.

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Secondary Outcome

Assessment of the ruler by emergency physicians recorded by an questionnaire.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2010/08/09
  •   89
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   14   Years
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Additional Inclusion Criteria

Pediatric patients that suffer from an emergency situation and require drugs that are not applicated rectally.

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Exclusion Criteria

Children with more than 140 cm of lenght.

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Addresses

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Sources of Monetary or Material Support

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    • Uniklinik Köln
    • Mr.  Universitäts-Professor  Bernhard  Roth 
    • Kerpener Str. 62
    • 50937   Köln
    • Germany
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    • ZOLL medical
    • 269 Mill Road
    • MA 01824  Chelmsford
    • United States
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • TK - Techniker KrankenkasseLandesvertretung Baden-Württemberg
    • Presselstr. 10
    • 70191  Stuttgart
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/08/27
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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.