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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00964639
First received: August 24, 2009
Last updated: January 25, 2013
Last verified: January 2013

August 24, 2009
January 25, 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 ] [ Designated as safety issue: No ]
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: Double Blind (Subject, Caregiver, 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
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00964639
FLACC2008
Yes
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