Effect of pregabalin on pain after surgery in children.

• Conditions: Idiopatic scoliosis; MedDRA version: 18.0Level: LLTClassification code 10039594Term: Scheuermann's diseaseSystem Organ Class: 100000004859; MedDRA version: 18.0Level: LLTClassification code 10039723Term: Scoliosis (and kyphoscoliosis), idiopathicSystem Organ Class: 100000004859; MedDRA version: 18.0Level: LLTClassification code 10049007Term: Spondylolisthesis NOSSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-000072-99-FI
• Lead Sponsor: Ilkka Helenius

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-24
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of pregabalin on postoperative pain given twice preoperatively and for five days postoperatively. Measured by oxycodone consumption.;Secondary Objective: To evaluate the effect of preoperative pregabalin on motor evoked potentials (latency, amplitude, currency needed to elucidate potentials) in spinal cord monitoring.<br>To evaluate the effects of perioperative pregabalin on prevalence of persistent postsurgical pain.<br>;Primary end point(s): 30% difference in oxycodone consumption.;Timepoint(s) of evaluation of this end point: 48 h postoperatively.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Decline in Incidence of persistent postsurgical pain;Timepoint(s) of evaluation of this end point: 12 months and 24 months postoperatively.