Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00017509

Trial Description

start of 1:1-Block title

Title

Course of postoperative pain in children after tonsillectomy - A prospective observational trial

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Even minor surgeries can lead to severe postoperative pain. Extracapsular tonsillectomies are part of the 25 most painful operations, intracapsular tonsillectomies (tonsillotomies) are less painful. Postoperative pain may cause dysphagia, dehydration and loss of weight. International recommendations on postoperative analgesia are controversial. This study as part of our internal quality management investigates the postoperative pain intensity in children aged 2-12 years treated with a standard analgesics scheme with ibuprofen "around the clock". The pain intensity is measured with the Children and Infants Postoperative Pain Scale (CHIPPS), the Faces Pain Scale - Revised (FPS-R) and the German Version of the Parents´ Postoperative Pain Measure (PPPM-D). Children with relevant pain get a rescue medication. We test the hypothesis, that not more than 30% of children need a rescue medication. Moreover, the daily fluids amount and the concordance of the PPPM-D to the age-appropriate reference scale are being monitored.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Tonsil surgery is one of the most painful operations in childhood. Extracapsular tonsillectomies are part of the 25 most painful operations, intracapsular tonsillectomies (tonsillotomies) are less painful. Postoperative pain may cause dysphagia, dehydration and loss of weight. International recommendations on postoperative analgesia are controversial. This study as part of our internal quality management investigates the postoperative pain intensity in children aged 2-12 years treated with a standard analgesics scheme with ibuprofen "around the clock". The pain intensity is measured with the Children and Infants Postoperative Pain Scale (CHIPPS), the Faces Pain Scale - Revised (FPS-R) and the German Version of the Parents´ Postoperative Pain Measure (PPPM-D). Children with relevant pain get a rescue medication. We test the hypothesis, that not more than 30% of children need a rescue medication. Moreover, the daily fluids amount and the concordance of the PPPM-D to the age-appropriate reference scale are being monitored.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00017509
  •   2019/07/04
  •   [---]*
  •   yes
  •   Approved
  •   5108-14, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   R07.0 -  Pain in throat
  •   R13.9 -  [generalization R13: Dysphagia]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Evaluation of postoperative pain in children after tonsil surgery
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Proportion of children with relevant pain during their in-Patient stay, measured with CHIPPS or FPS-R, and PPPM-D

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Impact of the preoperative sedation level on postoperative pain, daily fluids intake, concordance of the PPPM-D to reference scales.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/10/13
  •   158
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   2   Years
  •   12   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Children aged 2 - 12 years undergoing tonsil surgery

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Allergies or contraindications to Standard medication,
refusal to give informed consent,
insufficient German language skills,
developmental delay,
severe chronic diseases,
Transfer of the patient to an external ward

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Anästhesiologie und operative Intensivmedizin, Katholisches Klinikum Bochum
    • Bleichstraße 15
    • 44787  Bochum
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik für Anästhesiologie und operative Intensivmedizin, Katholisches Klinikum Bochum.
    • Mr.  Dr. med.  Philipp  Gude 
    • Bleichstraße 15
    • 44787  Bochum
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Anästhesiologie und operative Intensivmedizin, Katholisches Klinikum Bochum.
    • Mr.  Dr. med.  Philipp  Gude 
    • Bleichstraße 15
    • 44787  Bochum
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Anästhesiologie und operative Intensivmedizin, Katholisches Klinikum Bochum.
    • Bleichstraße 15
    • 44787  Bochum
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2017/01/11
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.