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

NCT02571491 | Completed Phase 2

• 2 other identifiers: FSJD-ESCOKETA-20102011-000407-41
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Progressive Infantile Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

• Cumulative Consumption of Epidural Morphine at 72h Postoperatively

  For the assessment of the related ketamine analgesic efficacy. Cumulative consumption of epidural morphine administered as loading dose, intraoperatively, of 0,3 mcg/kg/min until the surgery operation and 150mcg/Kg of Morphine hydrochloride 60min before extubation

  in the first 72 hours postoperatively

Secondary Outcomes (8)

• Change From Baseline in Pain Scores (Visual Analogue Scale)

  in the first 72 hours after surgery.

• Rates of significant adverse events

  every 4 hours from the begin until the end of the surgical operation

• Time to oral tolerability

  up to 6 months from the end of the surgical operation

• Time to First Postoperative Ambulation

  up to 6 months from the end of the surgical operation

• Time to postoperative recovery

  up to 6 months from the end of the surgical operation

Study Arms (2)

Ketamine Hydrochloride

EXPERIMENTAL

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.

Drug: Ketamine Hydrochloride; Drug: Remifentanil; Drug: Morphine hydrochloride

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo; Drug: Remifentanil; Drug: Morphine hydrochloride

Interventions

Ketamine Hydrochloride DRUG

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.

Also known as: KETOLAR 50 mg/ml

Ketamine Hydrochloride

Placebo OTHER

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

Also known as: 0,9 % physiological serum

Placebo

Remifentanil DRUG

at doses of 0.3 mcg / kg / min during and until the end of the surgical operation

Ketamine Hydrochloride; Placebo

Morphine hydrochloride DRUG

at the dose of 150 mcg / kg, 60 minutes before the extubation procedure and until 72 hours after operation by intravenous infusion

Ketamine Hydrochloride; Placebo

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Related Publications (4)

• 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.

  PMID: 12467992 BACKGROUND

• 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.

  PMID: 10846153 BACKGROUND

• 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.

  PMID: 14581110 BACKGROUND

• 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.

  PMID: 10467917 BACKGROUND

MeSH Terms

Interventions

Ketamine; Remifentanil

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marina Perelló Riera, MD

  Hospital Sant Joan de Déu Servicio de Anestesiología, Reanimación y Tratamiento del Dolor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 8, 2015
• Study Start: January 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: October 8, 2015

Record last verified: 2015-10

Locations

ES (1)