Back to resultsEfficacy of Ketamine for Improvement in Postoperative Pain Control After Spinal Fusion for Idiopathic Scoliosis
Primary Purpose
Idiopathic Scoliosis, Post-operative Pain
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Scoliosis
Eligibility 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
Sites / Locations
- Albany Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment Group
Placebo
Arm Description
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
Outcomes
Primary Outcome Measures
Patient Satisfaction
All the patients and parent will fill out a survey grading their level of satisfaction with their post-operative pain management
Secondary Outcome Measures
Pain Score
Pain scores will be collected from the nursing sheet
Opioid Use
Total Morphine consumption will be collected from PCA data
Length of Stay
Length of hospital stay from surgery to discharge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02651324
Brief Title
Efficacy of Ketamine for Improvement in Postoperative Pain Control After Spinal Fusion for Idiopathic Scoliosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Scoliosis, Post-operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A placebo (saline) will be given in place of ketamine
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Patient Satisfaction
Description
All the patients and parent will fill out a survey grading their level of satisfaction with their post-operative pain management
Time Frame
Through study completion, 48 hours
Secondary Outcome Measure Information:
Title
Pain Score
Description
Pain scores will be collected from the nursing sheet
Time Frame
Through study completion 48 hours
Title
Opioid Use
Description
Total Morphine consumption will be collected from PCA data
Time Frame
Through study completion, 48 hours
Title
Length of Stay
Description
Length of hospital stay from surgery to discharge
Time Frame
Through study completion, 48 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farzana Afroze, MD
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11733293
Citation
Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
Results Reference
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PubMed Identifier
20207747
Citation
Carstensen M, Moller AM. Adding ketamine to morphine for intravenous patient-controlled analgesia for acute postoperative pain: a qualitative review of randomized trials. Br J Anaesth. 2010 Apr;104(4):401-6. doi: 10.1093/bja/aeq041. Epub 2010 Mar 5.
Results Reference
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PubMed Identifier
22318834
Citation
Cha MH, Eom JH, Lee YS, Kim WY, Park YC, Min SH, Kim JH. Beneficial effects of adding ketamine to intravenous patient-controlled analgesia with fentanyl after the Nuss procedure in pediatric patients. Yonsei Med J. 2012 Mar;53(2):427-32. doi: 10.3349/ymj.2012.53.2.427.
Results Reference
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PubMed Identifier
16918659
Citation
DA Conceicao MJ, Bruggemann DA Conceicao D, Carneiro Leao C. Effect of an intravenous single dose of ketamine on postoperative pain in tonsillectomy patients. Paediatr Anaesth. 2006 Sep;16(9):962-7. doi: 10.1111/j.1460-9592.2006.01893.x.
Results Reference
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PubMed Identifier
10499950
Citation
Green SM, Clark R, Hostetler MA, Cohen M, Carlson D, Rothrock SG. Inadvertent ketamine overdose in children: clinical manifestations and outcome. Ann Emerg Med. 1999 Oct;34(4 Pt 1):492-7. doi: 10.1016/s0196-0644(99)80051-1.
Results Reference
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PubMed Identifier
22159259
Citation
Mathews TJ, Churchhouse AM, Housden T, Dunning J. Does adding ketamine to morphine patient-controlled analgesia safely improve post-thoracotomy pain? Interact Cardiovasc Thorac Surg. 2012 Feb;14(2):194-9. doi: 10.1093/icvts/ivr081. Epub 2011 Nov 28.
Results Reference
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PubMed Identifier
17576969
Citation
Michelet P, Guervilly C, Helaine A, Avaro JP, Blayac D, Gaillat F, Dantin T, Thomas P, Kerbaul F. Adding ketamine to morphine for patient-controlled analgesia after thoracic surgery: influence on morphine consumption, respiratory function, and nocturnal desaturation. Br J Anaesth. 2007 Sep;99(3):396-403. doi: 10.1093/bja/aem168. Epub 2007 Jun 18.
Results Reference
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PubMed Identifier
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Citation
Subramaniam K, Subramaniam B, Steinbrook RA. Ketamine as adjuvant analgesic to opioids: a quantitative and qualitative systematic review. Anesth Analg. 2004 Aug;99(2):482-95, table of contents. doi: 10.1213/01.ANE.0000118109.12855.07.
Results Reference
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PubMed Identifier
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Citation
Tsui BC, Wagner A, Mahood J, Moreau M. Adjunct continuous intravenous ketamine infusion for postoperative pain relief following posterior spinal instrumentation for correction of scoliosis: a case report. Paediatr Anaesth. 2007 Apr;17(4):383-6. doi: 10.1111/j.1460-9592.2006.02134.x.
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PubMed Identifier
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Citation
Yamauchi M, Asano M, Watanabe M, Iwasaki S, Furuse S, Namiki A. Continuous low-dose ketamine improves the analgesic effects of fentanyl patient-controlled analgesia after cervical spine surgery. Anesth Analg. 2008 Sep;107(3):1041-4. doi: 10.1213/ane.0b013e31817f1e4a.
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Citation
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Results Reference
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Efficacy of Ketamine for Improvement in Postoperative Pain Control After Spinal Fusion for Idiopathic Scoliosis
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