ASSESSMENT OF THE ANALGESIC EFFICACY AND TOLERABILITY OF THE PERIOPERATIVE ASSOCIATION OF KETAMINE WITH OPIATES AFTER POSTERIOR VERTEBRAL FUSION SURGERY IN CHILDREN WITH IDIOPATHIC SCOLIOSIS

• Conditions: POSTERIOR VERTEBRAL FUSION SURGERY IN CHILDREN WITH IDIOPATHIC SCOLIOSIS; MedDRA version: 14.1Level: LLTClassification code 10036804Term: Progressive infantile idiopathic scoliosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2011-000407-41-ES
• Lead Sponsor: FUNDACIÓ SANT JOAN DE DE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-24
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

a) Patients of both genders diagnosed with idiopathic scoliosis aged between 8 and 18 years old.
b) Patients of both genders diagnosed with idiopathic scoliosis and candidates for vertebral fusion corrective surgery with instrumentation.
c) Patients with ASA 1 or ASA 2.
d) Patients and/or parents/tutors consent to participate in the clinical trial.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a)Patients with chronic preoperative pain.
b)Patients with addiction to narcotics.
c)Patients with a history of allergy, contraindication or intolerance to the drugs used.
e)Patients unable to understand the patient-controlled analgesia system.
f)Patients with mental disorders.
g)Reoperated patients.
h)Patients requiring elective postoperative ventilation.
d)Pregnant patients.

Study & Design

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