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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00964639

Enrollment

Registered

2009-08-25

Start date

2009-08-31

Completion date

2013-01-31

Last updated

2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Postoperative Pain

Keywords

Pain, Postoperative, Local infiltration analgesia, Cerebral palsy, r-FLACC

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.

Interventions

DRUGRopivacaine

During the surgery infiltration with Naropine 2 mg/ml. The dosage in the infiltration is 2 mg/kg. Thereafter bolus 3 times a day

DRUGSaline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

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

Design outcomes

Primary

Measure	Time frame
Difference in pain measured with r-FLACC between the 2 groups	2 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026