We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02571491
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : October 8, 2015
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Fundació Sant Joan de Déu

Tracking Information
First Submitted Date  ICMJE September 28, 2015
First Posted Date  ICMJE October 8, 2015
Last Update Posted Date October 8, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
Cumulative Consumption of Epidural Morphine at 72h Postoperatively [ Time Frame: in the first 72 hours 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
  • Change From Baseline in Pain Scores (Visual Analogue Scale) [ Time Frame: in the first 72 hours after surgery. ]
    Pain scores at rest and on cough using a 10cm Visual Analogue Scale(0=no pain, 10=worst possible pain for the analgesic efficacy assessment of the association of Ketamine and opiates
  • Rates of significant adverse events [ Time Frame: every 4 hours from the begin until the end of the surgical operation ]
    To assess the tolerability of the association of ketamine and opiates
  • Time to oral tolerability [ Time Frame: up to 6 months from the end of the surgical operation ]
    To assess the efficacy of the association of ketamine and opiates, measuring the time needed from the surgery for reaching the oral tolerability
  • Time to First Postoperative Ambulation [ Time Frame: up to 6 months from the end of the surgical operation ]
    To assess the efficacy of the association of ketamine and opiates, measuring the time needed to being able to walk without assistance within the room or outside the room
  • Time to postoperative recovery [ Time Frame: up to 6 months from the end of the surgical operation ]
    Post operation period needed for each patient from the end of the surgery until hospital discharge by counting each patient postoperative hospital night admissions
  • Change From Baseline in Pain by sensorial test using the Voy Frey filament [ Time Frame: in the first 72 hours post surgery ]
    measure of the area of hyperalgesia of the inflamed skin and the length of the incision after 72 post surgery. The filaments is used to provide a range of forces to the skin of a test subject, in order to find the force at which the subject reacts because the sensation is painful.
  • Change From Baseline in Pain Scores (Visual Analogue Scale) [ Time Frame: at week 6 and after 3 and 6 months post surgery. ]
    Assessment of pain at week 6 and chronic pain after 3 and 6 months post-surgery using the Visual Analogue Scale pain scale
  • Change From Baseline in neuropathic pain using Douleur Neuropathique en 4 Questions (DN4) questionnaire [ Time Frame: at week 6 and after 3 and 6 months post surgery. ]
    The (DN4) questionnaire is a screening tool for neuropathic pain consisting of interview questions (DN4-interview) and physical tests. Two questions (I and II) were based on the interview of the patient and two questions (III and IV) were based on a standardized clinical examination
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Efficacy of Ketamine in Pediatric Patients With Idiopathic Scoliosis After Surgery
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Progressive Infantile Idiopathic Scoliosis
Intervention  ICMJE
  • 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 Name: KETOLAR 50 mg/ml
  • 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
    Other Name: 0,9 % physiological serum
  • 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
Study Arms  ICMJE
  • Experimental: Ketamine Hydrochloride

    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.
    Interventions:
    • Drug: Ketamine Hydrochloride
    • Drug: Remifentanil
    • Drug: Morphine hydrochloride
  • Placebo Comparator: Placebo

    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.
    Interventions:
    • Other: Placebo
    • Drug: Remifentanil
    • Drug: Morphine hydrochloride
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2015)
48
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02571491
Other Study ID Numbers  ICMJE FSJD-ESCOKETA-2010
2011-000407-41 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Fundació Sant Joan de Déu
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fundació Sant Joan de Déu
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Instituto de Salud Carlos III
Investigators  ICMJE
Principal Investigator: Marina Perelló Riera, MD Hospital Sant Joan de Déu Servicio de Anestesiología, Reanimación y Tratamiento del Dolor
PRS Account Fundació Sant Joan de Déu
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP