Back to resultsPostoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral Osteotomies
Primary Purpose
Postoperative Pain, Cerebral Palsy
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Pain, Postoperative, Local infiltration analgesia, Cerebral palsy, r-FLACC
Eligibility 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
Sites / Locations
- Departement of childrens orthopaedics, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Saline
Naropin
Arm Description
Outcomes
Primary Outcome Measures
Difference in pain measured with r-FLACC between the 2 groups
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00964639
Brief Title
Postoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral Osteotomies
Official Title
Postoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral Osteotomies. A Prospective, Randomized and Double-blinded Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Cerebral Palsy
Keywords
Pain, Postoperative, Local infiltration analgesia, Cerebral palsy, r-FLACC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Title
Naropin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
During the surgery infiltration with Naropine 2 mg/ml. The dosage in the infiltration is 2 mg/kg. Thereafter bolus 3 times a day
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
During the surgery infiltration with saline. Thereafter bolus 3 times a day
Primary Outcome Measure Information:
Title
Difference in pain measured with r-FLACC between the 2 groups
Time Frame
2 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Departement of childrens orthopaedics, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Postoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral Osteotomies
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