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Clinical Trials/NCT00964639
NCT00964639
Completed
Phase 4

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

University of Aarhus1 site in 1 country12 target enrollmentAugust 2009
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ConditionsPostoperative PainCerebral Palsy
InterventionsSalineRopivacaine
DrugsRopivacaineSaline

Overview

Phase
Phase 4
Intervention
Saline
Conditions
Postoperative Pain
Sponsor
University of Aarhus
Enrollment
12
Locations
1
Primary Endpoint
Difference in pain measured with r-FLACC between the 2 groups
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
January 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Saline

Intervention: Saline

Naropin

Intervention: Ropivacaine

Outcomes

Primary Outcomes

Difference in pain measured with r-FLACC between the 2 groups

Time Frame: 2 years

Study Sites (1)

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