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

NCT ID: NCT00964639

Last Updated: 2013-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Postoperative Pain Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Naropin

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Departement of childrens orthopaedics, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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FLACC2008

Identifier Type: -

Identifier Source: org_study_id

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