Clinical trial NCT02651324: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Idiopathic Scoliosis
Post-operative Pain
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Through study completion, 48 hours
Secondary outcomes:
measure: Pain Score
timeFrame: Through study completion 48 hours
measure: Opioid Use
timeFrame: Through study completion, 48 hours
measure: Length of Stay
timeFrame: Through study completion, 48 hours
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
affiliation: Albany Medical College
name: Farzana Afroze, MD
role: PRINCIPAL_INVESTIGATOR
References:
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