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
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Tracking Information | ||||
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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 |
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
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Original Primary Outcome Measures ICMJE |
Patient Satisfaction [ Time Frame: Through study completion, an average of 5-7 days ] | |||
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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. |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |