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

Phase 4

Completed

• Conditions: Postoperative Pain; Cerebral Palsy
• Interventions: Drug: Saline; Drug: Ropivacaine

• Registration Number: NCT00964639
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-25
• Last Update Posted: 2013-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	-
Naropin	Ropivacaine	-

Primary Outcome Measures

Name	Time	Method
Difference in pain measured with r-FLACC between the 2 groups	2 years

Trial Locations

Locations (1)

Departement of childrens orthopaedics, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark