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

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.

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Key information

Conditions

Postoperative Pain Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Departement of childrens orthopaedics, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

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

Saline

Drug

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

Primary outcomes

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

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Aug 25, 2009
Registry last updated: Jan 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed