NCT02571491

Comparison of the Efficacy of Ketamine in Pediatric Patients With Idiopathic Scoliosis After Surgery

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Fundació Sant Joan de Déu · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Progressive Infantile Idiopathic Scoliosis

Interventions

Type	Name	Description
DRUG	Ketamine Hydrochloride	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.
OTHER	Placebo	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
DRUG	Remifentanil	at doses of 0.3 mcg / kg / min during and until the end of the surgical operation
DRUG	Morphine hydrochloride	at the dose of 150 mcg / kg, 60 minutes before the extubation procedure and until 72 hours after operation by intravenous infusion

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2015-10-08
• Last updated: 2015-10-08

Locations

1 site across 1 country: Spain