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

University of Aarhus

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Cerebral Palsy

Treatments: Drug: Ropivacaine; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00964639

FLACC2008

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Saline

Placebo Comparator group

Treatment:

Drug: Saline

Naropin

Active Comparator group

Treatment:

Drug: Ropivacaine