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 : 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
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Scoliosis Post-operative Pain||Drug: Ketamine Other: Placebo||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
Placebo Comparator: Placebo
A placebo (saline) will be given in place of ketamine
Other Name: Saline
- 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
- 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
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
|United States, New York|
|Albany Medical Center|
|Albany, New York, United States, 12208|
|Principal Investigator:||Farzana Afroze, MD||Albany Medical College|