POSTERIOR VERTEBRAL FUSION SURGERY IN CHILDREN WITH IDIOPATHIC SCOLIOSIS MedDRA version: 14.1 Level: LLT Classification code 10036804 Term: Progressive infantile idiopathic scoliosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: KETOLAR 50 mg/ml solución inyectable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: KETAMINA HIDROCLORURO
CAS Number: 1867-66-9
Other descriptive name: KETAMINE HYDROCHLO
Sponsors
FUNDACIÓ SANT JOAN DE DEU
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the analgesic efficacy of ketamine in the first 72 hours after surgery, measuring the total intake of morphine chloride.;Secondary Objective: ?To assess the analgesic efficacy of the association of Ketamine and opiates after surgery, with pain assessment. ?To assess the tolerability of the association of ketamine and opiates after surgery, considering the incidence of adverse effects. ?To assess the efficacy of the association of ketamine and opiates after surgery, considering the start of oral tolerance. ?To assess the efficacy of the association of ketamine and opiates after surgery, considering the start of deambulation. ?To study the efficacy of the combination of ketamine and opiates after surgery; by evaluating duration of hospital stay. ?To study the analgesic efficacy of the combination of ketamine and opiates at 72 hours after surgery, by assessing the post-operative hyperalgesic zone. ?To study the analgesic efficacy of the combination of ketamine and opiates by considering the incidence of pain 6 weeks after surgery and of chronic pain at 3 and 6 months after surgery.;Primary end point(s): Total morphine intake during the first 72 hours after the surgical intervention, measured in mg/kg body weight. The total morphine intake is recorded in the PCA infusion pumps.;Timepoint(s) of evaluation of this end point: Intergroup variables of the study will be compared with the following tests: Chi-squared for a comparison of proportions and the Student?s t-test to compare the means and ordinal data. In a contrasting hypothesis, a statistically significant difference will be considered to exist between the means (or correlation between variables) when the significance level is below 0.05. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ?Pain assessment by the numerical pain scale in resting state and in movement (coughing) every 4 h after completing post-operative morphine infusion. ?Assessment of the incidence of the following adverse effects every 4 hours until completing the post-operative morphine infusion: nausea, vomiting and pruritus, state of sedation, presence of dysphoria, hallucinations, nightmares, diplopia and respiratory depression requiring naloxone. ? Post-operative period until start of oral tolerance. ? Post-operative period until start of deambulation. ? Post-operative period until hospital discharge (post-operative nights of hospital stay). ? Measurement of the hyperalgesic zone of the peri-incisional inflamed and non-inflamed skin 72 hours post-surgery and the length of the incision, assessing the mechanical pain threshold by the quantitative sensorial test. ?Incidence of pain at 6 weeks and chronic pain at 3 and 6 months post-surgery by the numerical pain scale and the DN4 questionnaire (6 weeks and 6 months).;Timepoint(s) of evaluation of this end point: Intergroup variables of the study will be compared with the following tests: Chi-squared for a comparison of proportions and the Student?s t-test to compare the means and ordinal data. In a contrasting hypothesis, a statistically significant difference will be considered to exist between the means (or correlation between variables) when the significance level is below 0.05. | — |
Countries
Spain
Contacts
Public ContactFUNDACIÓ SANT JOAN DE DEU
FUNDACIÓ SANT JOAN DE DEU
Outcome results
None listed