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

Postoperative Pain Clinical Trial

Official title:

Postoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral Osteotomies. A Prospective, Randomized and Double-blinded Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964639
• Other study ID #: FLACC2008
• Status: Completed
• Phase: Phase 4
• First received: August 24, 2009
• Last updated: January 25, 2013
• Start date: August 2009
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Pain, Postoperative
• Postoperative Pain

Intervention

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
• Saline
During the surgery infiltration with saline. Thereafter bolus 3 times a day

Locations

Country	Name	City	State
Denmark	Departement of childrens orthopaedics, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in pain measured with r-FLACC between the 2 groups		2 years	No