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

• ClinicalTrials.gov Identifier: NCT02651324
• Recruitment Status: Unknown
• First Posted: January 11, 2016
• Last Update Posted: July 2, 2017
• Sponsor: Albany Medical College
• Information provided by (Responsible Party): Farzana Afroze, Albany Medical College

Tracking Information

• First Submitted Date: January 6, 2016
• First Posted Date: January 11, 2016
• Last Update Posted Date: July 2, 2017
• Actual Study Start Date: May 2013
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 29, 2017)

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

• Original Primary Outcome Measures (submitted: January 7, 2016): Patient Satisfaction [ Time Frame: Through study completion, an average of 5-7 days ]

Current Secondary Outcome Measures (submitted: June 29, 2017)

• 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

Original Secondary Outcome Measures (submitted: January 7, 2016)

• Pain Score [ Time Frame: Through study completion, an average of 5-7 days ]
• Opioid Use [ Time Frame: Through study completion, an average of 5-7 days ]
• Length of Stay [ Time Frame: Through study completion, an average of 5-7 days ]
  Length of hospital stay from surgery to discharge

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

• Idiopathic Scoliosis
• Post-operative Pain

Intervention

• Drug: Ketamine
• Other: Placebo
  Other Name: Saline

Study Arms

• 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.
  Intervention: Drug: Ketamine
• Placebo Comparator: Placebo
  A placebo (saline) will be given in place of ketamine
  Intervention: Other: Placebo

Publications *

• 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.
• Carstensen M, Møller 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. Review.
• 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.
• DA Conceição MJ, Bruggemann DA Conceição D, Carneiro Leão C. Effect of an intravenous single dose of ketamine on postoperative pain in tonsillectomy patients. Paediatr Anaesth. 2006 Sep;16(9):962-7.
• 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.
• 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.
• Michelet P, Guervilly C, Hélaine 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. Epub 2007 Jun 18.
• 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. Review.
• 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.
• 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.
• Zakine J, Samarcq D, Lorne E, Moubarak M, Montravers P, Beloucif S, Dupont H. Postoperative ketamine administration decreases morphine consumption in major abdominal surgery: a prospective, randomized, double-blind, controlled study. Anesth Analg. 2008 Jun;106(6):1856-61. doi: 10.1213/ane.0b013e3181732776.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 7, 2016): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2017
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02651324
• Other Study ID Numbers: 3497
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Farzana Afroze, Albany Medical College
• Original Responsible Party: Same as current
• Current Study Sponsor: Albany Medical College
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Farzana Afroze, MD; Albany Medical College

• PRS Account: Albany Medical College
• Verification Date: June 2017