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Clinical Trials/EUCTR2015-000072-99-FI
EUCTR2015-000072-99-FI
Active, not recruiting
Not Applicable

EFFECT OF PREGABALIN ON IMMEDIATE POSTOPERATIVE AND LONGTERM PAIN AND SPINAL MONITORING IN CHILDREN UNDERGOING INSTRUMENTED SPINAL SURGERY. A placebo-controlled randomized clinical trial

Ilkka Helenius0 sitesApril 24, 2015
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ConditionsIdiopatic scoliosisMedDRA version: 18.0Level: LLTClassification code 10039594Term: Scheuermann's diseaseSystem Organ Class: 100000004859MedDRA version: 18.0Level: LLTClassification code 10039723Term: Scoliosis (and kyphoscoliosis), idiopathicSystem Organ Class: 100000004859MedDRA version: 18.0Level: LLTClassification code 10049007Term: Spondylolisthesis NOSSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsLyrica

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Idiopatic scoliosis
Sponsor
Ilkka Helenius
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 24, 2015
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Ilkka Helenius

Eligibility Criteria

Inclusion Criteria

  • •1\.Adolescent (10\-20 years) undergoing spinal fusion for idiopathic scoliosis, spondylolisthesis or Scheuermann kyphosis.
  • •2\.Posterior spinal fusion
  • •3\.No contraindication for Pregabalin use
  • •4\.ASA I\-III
  • •5\.Written informed consent
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 50
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 10
  • •F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

  • •1\.Other spinal pathology or other associated medical condition
  • •2\.Major neurologic developmental delay
  • •3\.Need for anterior surgery or for vertebral column resection.
  • •4\.Preoperative opioid use
  • •5\.Inability to use PCA

Outcomes

Primary Outcomes

Not specified

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