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

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ClinicalTrials.gov Identifier: NCT02651324
Recruitment Status : 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

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.

Condition or disease Intervention/treatment Phase
Idiopathic Scoliosis Post-operative Pain Drug: Ketamine Other: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Controlled Trial Evaluating the Efficacy of Ketamine for Improvement in Postoperative Pain Control After Spinal Fusion for Idiopathic Scoliosis
Actual Study Start Date : May 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
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.
Drug: Ketamine
Placebo Comparator: Placebo
A placebo (saline) will be given in place of ketamine
Other: Placebo
Other Name: Saline




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pain Score [ Time Frame: Through study completion 48 hours ]
    Pain scores will be collected from the nursing sheet

  2. Opioid Use [ Time Frame: Through study completion, 48 hours ]
    Total Morphine consumption will be collected from PCA data

  3. Length of Stay [ Time Frame: Through study completion, 48 hours ]
    Length of hospital stay from surgery to discharge



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651324


Locations
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United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Sponsors and Collaborators
Albany Medical College
Investigators
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Principal Investigator: Farzana Afroze, MD Albany Medical College

Publications:

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Responsible Party: Farzana Afroze, Anesthesiologist, Albany Medical College
ClinicalTrials.gov Identifier: NCT02651324     History of Changes
Other Study ID Numbers: 3497
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
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Pain, Postoperative
Scoliosis
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action