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Treatment Group for Postoperative Pain
Phase 4
Waitlist Available
Led By Farzana Afroze, MD
Research Sponsored by Albany Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion 48 hours
Awards & highlights
Study 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.
Eligible Conditions
- Idiopathic Scoliosis
- Postoperative Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion 48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient Satisfaction
Secondary outcome measures
Length of Stay
Opioid Use
Pain Score
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment GroupExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
A placebo (saline) will be given in place of ketamine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved
Find a Location
Who is running the clinical trial?
Albany Medical CollegeLead Sponsor
91 Previous Clinical Trials
11,447 Total Patients Enrolled
1 Trials studying Postoperative Pain
350 Patients Enrolled for Postoperative Pain
Farzana Afroze, MDPrincipal InvestigatorAlbany Medical College
1 Previous Clinical Trials
600 Total Patients Enrolled
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