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

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    N/A
  • Placebo (OTHER)
    N/A

Condition or Disease

  • Idiopathic Scoliosis
  • Post-operative Pain

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: Child, Adult, Older Adult
    Enrollment: 50 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: May 01, 2013 ACTUAL
    Primary Completion: Dec 01, 2017 ESTIMATED
    Completion Date: Dec 01, 2017 ESTIMATED
    Study First Posted: Jan 11, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jun 29, 2017

    Sponsors / Collaborators

    Lead Sponsor: Albany Medical College
    Responsible Party: N/A

    Location

    Albany, New York, USA

    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.

    Participant Groups

    • 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.

    • A placebo (saline) will be given in place of ketamine

    Eligibility Criteria

    Sex: All
    Age Groups: Child / Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • All the patients and parent will fill out a survey grading their level of satisfaction with their post-operative pain management

    Secondary Outcomes

    • Pain scores will be collected from the nursing sheet

    • Total Morphine consumption will be collected from PCA data

    • Length of hospital stay from surgery to discharge

    More Details

    NCT Number: NCT02651324
    Other IDs: 3497
    Study URL: https://clinicaltrials.gov/study/NCT02651324
    Last updated: Sep 29, 2023