Comparison of the Efficacy of Ketamine in Pediatric Patients With Idiopathic Scoliosis After Surgery
Condition: Progressive Infantile Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Comparison of the Efficacy of ketamine measuring the total consumption of morphine in
      pediatric patients with idiopathic scoliosis
    

Detailed description: 
      A randomized unicenter clinical trial, parallel, double-blind study, placebo-controlled
      group.

      Involve the participation of Pediatric patients, aged between 11 and 18 years, of both
      genders, diagnosed with idiopathic scoliosis and posterior spinal fusion surgery candidates
      included in the Anesthesia Physical Classification System (ASA) 1 or 2 classes.

      Both groups received remifentanil at doses of 0.3 mcg / Kg / min before surgical procedure
      and a bolus of 150 mcg / Kg of morphine hydrochloride, approximately 60 minutes before
      extubation, followed by PCA morphine hydrochloride administration.

      The patients in the experimental group are treated with a combination of ketamine,
      remifentanil hydrochloride and morphine while the control group will be treated with a
      combination of saline, remifentanil and morphine hydrochloride.

      Treatment of patients in the study is initiated during the induction of anesthesia and ends
      at the hospital discharge.

      The total duration of patient participation in the study is 6 months. During treatment the
      patients being admitted are monitored at regular intervals, at week 6, after the 3rd month
      and at 6 months post-intervention to assess the incidence of chronic pain.

      The entire study duration is approximately 24 months. The hypothesis of the study is that the
      combination of subanesthetic doses of ketamine to opioid drugs during the perioperative
      period reduces central sensitization processes, resulting in lower consumption of
      postoperative morphine with fewer adverse effects, postoperative faster recovery and less
      incidence of chronic pain.

      The post-operative analgesia is induced by the use of opioids or other analgesics associated
      with loco-regional techniques. The technique used in the investigators' center is the
      patient-controlled analgesia (PCA) with the administration of intravenous opioids.

      The association of ketamine to opioid treatment could reduce the consumption of these and can
      be useful in surgery. No clinical trials have been conducted in children with scoliosis, who
      underwent posterior lumbar fusion surgical procedure, evaluating the efficacy of
      post-operative association of ketamine to opioid drugs for both intra and post-operative
      periods.
    

Intervention name(s): Ketamine Hydrochloride; Placebo; Remifentanil; Morphine hydrochloride
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): 50 mg/ml, IV (in the vein) during surgery operation, followed by IV ketamine hydrocloride perfusion 2mcg/Kg/min before and until 72 hours after operation Number of Cycles: until progression or unacceptable toxicity develops.; 50 mg/ml, IV (in the vein) during surgery operation, followed by IV placebo perfusion 2mcg/Kg/min before and until 72 hours after operation; at doses of 0.3 mcg / kg / min during and until the end of the surgical operation; at the dose of 150 mcg / kg, 60 minutes before the extubation procedure and until 72 hours after operation by intravenous infusion
Other intervention name(s): KETOLAR 50 mg/ml; 0,9 % physiological serum
Intervention MeSH terms: Ketamine; Morphine; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment