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

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ClinicalTrials.gov Identifier: NCT00964639
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : January 28, 2013
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

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 or disease Intervention/treatment Phase
Postoperative Pain Cerebral Palsy Drug: Ropivacaine Drug: Saline Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2009
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Difference in pain measured with r-FLACC between the 2 groups [ Time Frame: 2 years ]

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964639

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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00964639     History of Changes
Other Study ID Numbers: FLACC2008
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013

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