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

Fundació Sant Joan de Déu

Status and phase: Completed; Phase 2

Conditions: Progressive Infantile Idiopathic Scoliosis

Treatments: Drug: Morphine hydrochloride; Drug: Ketamine Hydrochloride; Other: Placebo; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02571491

2011-000407-41 (EudraCT Number)

FSJD-ESCOKETA-2010

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients of both genders diagnosed with idiopathic scoliosis aged between 8 and 18 years old.
2. Patients of both genders diagnosed with idiopathic scoliosis and candidates for vertebral fusion corrective surgery with instrumentation.
3. Patients with ASA 1 or ASA 2.
4. Patients and/or parents/tutors consent to participate in the clinical trial.

Exclusion criteria

1. Patients with chronic preoperative pain.
2. Patients with addiction to narcotics.
3. Patients with a history of allergy, contraindication or intolerance to the drugs used.
4. Patients unable to understand the patient-controlled analgesia system.
5. Patients with mental disorders.
6. Reoperated patients.
7. Patients requiring elective postoperative ventilation.
8. Pregnant patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

Ketamine Hydrochloride

Experimental group

Description:

Received a combination of ketamine, remifentanil and morphine hydrochloride established by the following dosage regimen: * KETAMINE HYDROCHLORIDE 0,5mg/Kg Intravenous bolus administered during the anesthetic induction, followed by 2 mcg / Kg / min of intravenous infusion during and after surgery until 72 hours postoperation * during surgery remifentanil 0,3 mcg / kg / min. * at the end of the operation morphine hydrochloride150 mcg / kg, PCA infusion postoperatively.

Treatment:

Drug: Ketamine Hydrochloride

Drug: Morphine hydrochloride

Drug: Remifentanil

Placebo

Placebo Comparator group

Description:

Received a combination of physiological serum, remifentanil and morphine hydrochloride established by the following dosage regimen: * 0,9 % physiological serum 0,5mg/Kg administered by an intravenous (IV) line during the anesthetic induction, followed by 2 mcg / Kg / min of intravenous infusion during and after surgery until 72 hours postoperation * during surgery remifentanil 0.3 mcg / kg / min. * at the end of the operation morphine hydrochloride150 mcg / kg, PCA infusion postoperatively.

Treatment:

Other: Placebo

Drug: Morphine hydrochloride

Drug: Remifentanil