Clinical trial NCT02571491: Comparison of the Efficacy of Ketamine in Pediatric Patients With Idiopathic Scoliosis After Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Progressive Infantile Idiopathic Scoliosis
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2015-10-08
Enrollment: 48
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative Consumption of Epidural Morphine at 72h Postoperatively
timeFrame: in the first 72 hours postoperatively
Secondary outcomes:
measure: Change From Baseline in Pain Scores (Visual Analogue Scale)
timeFrame: in the first 72 hours after surgery.
measure: Rates of significant adverse events
timeFrame: every 4 hours from the begin until the end of the surgical operation
measure: Time to oral tolerability
timeFrame: up to 6 months from the end of the surgical operation
measure: Time to First Postoperative Ambulation
timeFrame: up to 6 months from the end of the surgical operation
measure: Time to postoperative recovery
timeFrame: up to 6 months from the end of the surgical operation
measure: Change From Baseline in Pain by sensorial test using the Voy Frey filament
timeFrame: in the first 72 hours post surgery
measure: Change From Baseline in Pain Scores (Visual Analogue Scale)
timeFrame: at week 6 and after 3 and 6 months post surgery.
measure: Change From Baseline in neuropathic pain using Douleur Neuropathique en 4 Questions (DN4) questionnaire
timeFrame: at week 6 and after 3 and 6 months post surgery.
Other outcomes:
Locations:
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona
Study officials:
affiliation: Hospital Sant Joan de Déu Servicio de Anestesiología, Reanimación y Tratamiento del Dolor
name: Marina Perelló Riera, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mao J. Opioid-induced abnormal pain sensitivity: implications in clinical opioid therapy. Pain. 2002 Dec;100(3):213-217. doi: 10.1016/S0304-3959(02)00422-0. No abstract available.
citation: Woolf CJ, Salter MW. Neuronal plasticity: increasing the gain in pain. Science. 2000 Jun 9;288(5472):1765-9. doi: 10.1126/science.288.5472.1765.
citation: Angst MS, Koppert W, Pahl I, Clark DJ, Schmelz M. Short-term infusion of the mu-opioid agonist remifentanil in humans causes hyperalgesia during withdrawal. Pain. 2003 Nov;106(1-2):49-57. doi: 10.1016/s0304-3959(03)00276-8.
citation: Schmid RL, Sandler AN, Katz J. Use and efficacy of low-dose ketamine in the management of acute postoperative pain: a review of current techniques and outcomes. Pain. 1999 Aug;82(2):111-125. doi: 10.1016/S0304-3959(99)00044-5.