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

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

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.

Condition Intervention Phase
Postoperative Pain
Cerebral Palsy
Drug: Ropivacaine
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral Osteotomies. A Prospective, Randomized and Double-blinded Study

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Difference in pain measured with r-FLACC between the 2 groups [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: August 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline Drug: Saline
During the surgery infiltration with saline. Thereafter bolus 3 times a day
Active Comparator: Naropin 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


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00964639

Departement of childrens orthopaedics, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
  More Information

Responsible Party: University of Aarhus Identifier: NCT00964639     History of Changes
Other Study ID Numbers: FLACC2008 
Study First Received: August 24, 2009
Last Updated: January 25, 2013
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
Local infiltration analgesia
Cerebral palsy

Additional relevant MeSH terms:
Pain, Postoperative
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on October 27, 2016