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Postoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral Osteotomies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00964639
First Posted: August 25, 2009
Last Update Posted: January 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Aarhus
August 24, 2009
August 25, 2009
January 28, 2013
August 2009
January 2013   (Final data collection date for primary outcome measure)
Difference in pain measured with r-FLACC between the 2 groups [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00964639 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Postoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral Osteotomies
Postoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral Osteotomies. A Prospective, Randomized and Double-blinded Study

This study is a comparison of postoperative pain in children with cerebral palsy after surgery on the hip or femur. One group is treated with p.o. (by mouth) or intravenous (i.v.) analgesia, and the other group is treated with local infiltration analgesia with Naropine.

Pain is measured with r-FLACC, a pain-score validated for children with cerebral palsy.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Postoperative Pain
  • Cerebral Palsy
  • Drug: Ropivacaine
    During the surgery infiltration with Naropine 2 mg/ml. The dosage in the infiltration is 2 mg/kg. Thereafter bolus 3 times a day
  • Drug: Saline
    During the surgery infiltration with saline. Thereafter bolus 3 times a day
  • Placebo Comparator: Saline
    Intervention: Drug: Saline
  • Active Comparator: Naropin
    Intervention: Drug: Ropivacaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
January 2013
January 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age under 18
  • informed consent
  • Postoperative cast with spica

Exclusion Criteria:

  • Previous surgery in the same hip
  • Other surgical procedure planned at the same time
  • Bilateral surgery
  • Previous allergic reaction to local analgesia
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00964639
FLACC2008
Yes
Not Provided
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University of Aarhus
University of Aarhus
Not Provided
Not Provided
University of Aarhus
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP