Progressive Infantile Idiopathic Scoliosis Clinical Trial
Official title:
Assessment of the Analgesic Efficacy and Tolerability of the Perioperative Association of the Ketamine With Opiates After Posterior Vertebral Fusion Surgery in Children With Idiopathic Scoliosis
Comparison of the Efficacy of ketamine measuring the total consumption of morphine in pediatric patients with idiopathic scoliosis
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.
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