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Completed

NCT Number: NCT02651324

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

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.

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Key information

Conditions

Idiopathic Scoliosis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post-operative Pain Postoperative Complications Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Albany Medical Center

Albany, New York, 12208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

Placebo

Other

Other names: Saline

Primary outcomes

  1. 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. Patient Satisfaction Score from a scale of 1 - 4 was used -

    • Unsatisfied
    • Moderately satisfied 3 - Generally satisfied 4 - Very satisfied No other subscales were included.

Secondary outcomes

  1. Pain Score

    Time frame: Through study completion 48 hours

    Pain scores will be collected from the nursing sheet. Pain score was measured using "self-rating numeric scale" a scale from 1 to 10, where 1 is minimum pain and 10 is maximum pain.

    No other subscales were done.

  2. Opioid Use

    Time frame: Through study completion, 48 hours

    Total Morphine consumption will be collected from Patient Controlled Analgesia (PCA) morphine pump. The secondary outcome measure was total morphine consumption difference in 48hrs.

  3. Length of Stay

    Time frame: Through study completion, 48 hours

    Length of hospital stay from surgery to discharge

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2016
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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