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
  Purpose

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

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964639

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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov 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:
Pain
Postoperative
Local infiltration analgesia
Cerebral palsy
r-FLACC

Additional relevant MeSH terms:
Cerebral Palsy
Pain, Postoperative
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014