Postoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral Osteotomies
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.
|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|
- Difference in pain measured with r-FLACC between the 2 groups [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Saline||
During the surgery infiltration with saline. Thereafter bolus 3 times a day
|Active Comparator: Naropin||
During the surgery infiltration with Naropine 2 mg/ml. The dosage in the infiltration is 2 mg/kg. Thereafter bolus 3 times a day