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
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
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Neurologic Manifestations
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014