Effect of pregabalin on pain after surgery in children.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000072-99-FI

Enrollment

Registered

2015-04-24

Start date

2015-05-06

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopatic scoliosis MedDRA version: 18.0 Level: LLT Classification code 10039594 Term: Scheuermann's disease System Organ Class: 100000004859 MedDRA version: 18.0 Level: LLT Classification code 10039723 Term: Scoliosis (and kyphoscoliosis), idiopathic System Organ Class: 100000004859 MedDRA version: 18.0 Level: LLT Classification code 10049007 Term: Spondylolisthesis NOS System Organ Class: 100000004859

Interventions

Trade Name: Lyrica Pharmaceutical Form: Capsule, hard CAS Number: 148553-50-8 Other descriptive name: PREGABALIN Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placeb

Eligibility

Sex/Gender

All

Inclusion 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 F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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. To evaluate the effects of perioperative pregabalin on prevalence of persistent postsurgical pain. ;Primary end point(s): 30% difference in oxycodone consumption.;Timepoint(s) of evaluation of this end point: 48 h postoperatively.	—

Measure

Time frame

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. To evaluate the effects of perioperative pregabalin on prevalence of persistent postsurgical pain. ;Primary end point(s): 30% difference in oxycodone consumption.;Timepoint(s) of evaluation of this end point: 48 h postoperatively.

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Secondary

Measure	Time frame
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.	—

Countries

Finland

Contacts

Public ContactTurku University Hospital

Ilkka Helenius

ilkka.helenius@tyks.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026