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Efficacy of Ketamine for Improvement in Postoperative Pain Control After Spinal Fusion for Idiopathic Scoliosis

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: NCT02651324
Recruitment Status : Unknown
Verified June 2017 by Farzana Afroze, Albany Medical College.
Recruitment status was:  Active, not recruiting
First Posted : January 11, 2016
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Farzana Afroze, Albany Medical College

Tracking Information
First Submitted Date  ICMJE January 6, 2016
First Posted Date  ICMJE January 11, 2016
Last Update Posted Date July 2, 2017
Actual Study Start Date  ICMJE May 2013
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2017)
Patient Satisfaction [ Time Frame: Through study completion, 48 hours ]
All the patients and parent will fill out a survey grading their level of satisfaction with their post-operative pain management
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
Patient Satisfaction [ Time Frame: Through study completion, an average of 5-7 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2017)
  • Pain Score [ Time Frame: Through study completion 48 hours ]
    Pain scores will be collected from the nursing sheet
  • Opioid Use [ Time Frame: Through study completion, 48 hours ]
    Total Morphine consumption will be collected from PCA data
  • Length of Stay [ Time Frame: Through study completion, 48 hours ]
    Length of hospital stay from surgery to discharge
Original Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
  • Pain Score [ Time Frame: Through study completion, an average of 5-7 days ]
  • Opioid Use [ Time Frame: Through study completion, an average of 5-7 days ]
  • Length of Stay [ Time Frame: Through study completion, an average of 5-7 days ]
    Length of hospital stay from surgery to discharge
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Ketamine for Improvement in Postoperative Pain Control After Spinal Fusion for Idiopathic Scoliosis
Official Title  ICMJE A Prospective, Randomized, Double-Blind, Controlled Trial Evaluating the Efficacy of Ketamine for Improvement in Postoperative Pain Control After Spinal Fusion for Idiopathic Scoliosis
Brief Summary This study hypothesizes that the addition of a low-dose ketamine infusion to usual post-operative pain management will improve pain control as evidenced by an improvement in post-operative pain scores for patients undergoing spinal fusion for idiopathic scoliosis.
Detailed Description

After consenting, patients will be randomized by the pharmacy. In the operating room patients will receive ketamine/placebo 0.5mg/kg bolus prior to the surgical incision, followed by ketamine/placebo 0.2mg/kg continuous infusion up to 48hours. All the patients will also receive 15mg/k IV acetaminophen at the end of the surgery, followed by every 6hr for 48hrs. Rest of the pain regimen will be the usual post-operative pain management for spinal fusion for idiopathic scoliosis, which includes morphine PCA, IV ketorolac from POD 1, and flexaril from POD 1.

All the patients and parents will fill out a survey at 0hr, 24hr and 48hr grading their level of satisfaction with the post-operative pain.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Idiopathic Scoliosis
  • Post-operative Pain
Intervention  ICMJE
  • Drug: Ketamine
  • Other: Placebo
    Other Name: Saline
Study Arms  ICMJE
  • Experimental: Treatment Group
    A ketamine bolus of 0.5mg/kg will be given and then the ketamine infusion of 0.2 mg/kg/hr will be initiated prior to incision. Intra-operative opioids will be at the discretion of the attending anesthesiologist. Postoperative management will include continuation of the study drug as well as a standardized morphine patient-controlled analgesia (PCA) and acetaminophen 15 mg/kg IV every 6 hours. On postoperative day 1, patients are started on ketorolac 0.5 mg/kg up to 15 mg IV q8h. On postoperative day 2 they are transitioned to ibuprofen 10 mg/kg up to 600 mg. The ketamine infusion will continue for 48 hours post operatively at which point the PCA is discontinued and patients are transitioned to oral pain medications (Roxicet or Lortab and Flexeril) as per the current protocol.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    A placebo (saline) will be given in place of ketamine
    Intervention: Other: Placebo
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 7, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA I, II, III
  • Presenting for spinal fusion for idiopathic scoliosis
  • English-speaking and able to give assent

Exclusion Criteria:

  • Any contraindication to ketamine
  • Previous spinal surgery
  • Opioid dependence
  • Chronic pain condition
  • Significant developmental delay
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02651324
Other Study ID Numbers  ICMJE 3497
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Farzana Afroze, Albany Medical College
Study Sponsor  ICMJE Albany Medical College
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Farzana Afroze, MD Albany Medical College
PRS Account Albany Medical College
Verification Date June 2017

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