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

Albany Medical College

Status and phase: Completed; Phase 4

Conditions: Post-operative Pain; Idiopathic Scoliosis

Treatments: Drug: Ketamine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02651324

3497

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

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.

Treatment:

Drug: Ketamine

Placebo

Placebo Comparator group

Description:

A placebo (saline) will be given in place of ketamine

Treatment:

Other: Placebo