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Clinical Trials/EUCTR2011-000407-41-ES
EUCTR2011-000407-41-ES
Active, not recruiting
Not Applicable

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

FUNDACIÓ SANT JOAN DE DE0 sitesJanuary 24, 2012
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ConditionsPOSTERIOR VERTEBRAL FUSION SURGERY IN CHILDREN WITH IDIOPATHIC SCOLIOSISMedDRA version: 14.1Level: LLTClassification code 10036804Term: Progressive infantile idiopathic scoliosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsKETOLAR 50 mg/ml solución inyectable

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
POSTERIOR VERTEBRAL FUSION SURGERY IN CHILDREN WITH IDIOPATHIC SCOLIOSIS
Sponsor
FUNDACIÓ SANT JOAN DE DE
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 24, 2012
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
FUNDACIÓ SANT JOAN DE DE

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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