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Completed

NCT Number: NCT01531439

Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery

There will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose. The trial is designed to determine if a higher dose of naloxone infusion will reduce side effects from opioid therapy in patients who have undergone spine fusion for scoliosis.

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Key information

Conditions

Pain, Postoperative Bone Diseases Musculoskeletal Diseases Nausea Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Scoliosis Signs and Symptoms Signs and Symptoms, Digestive Spinal Curvatures Spinal Diseases Vomiting

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

Currently, patients undergoing spinal fusion for scoliosis are routinely given patient controlled analgesia (PCA) for pain control postoperatively. PCA therapy is typically combined with an ultra low dose naloxone infusion because of the established benefit of reduced pruritis and nausea. The investigators hypothesize that using a higher dose naloxone infusion may lead to further improvement in pruritis and nausea and may improve GI function. Improvement in bowel function could lead to faster initiation of oral intake as well as transition to oral pain medication and even decreased length of stay.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Idiopathic scoliosis requiring spine fusion surgery
  • Age 10-21 years

Exclusion criteria

  • Inability to understand PCA instructions
  • Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine
  • Chronic opioid therapy > 2 months
  • Non-English speaking

Treatment and study plan

naloxone

Drug

Naloxone infusion 0.5 mcg/kg/hr

Other names: Narcan

Primary outcomes

  1. Number of Hours Until Tolerating Oral Intake

    Time frame: Assessed daily in hospital while in hospital until taking orals, average 4 days.

    Defined as time when awakening after surgery until tolerating orals.

Secondary outcomes

  1. Severity of Itching

    Time frame: Assessed daily while in hospital requiring PCA

    Visual analog scale presented to subject to complete daily. Minimum value 0 "none" to maximum value 10 "worst possible". Higher scores represent worse outcome.

    Title of scale "Itching VAS".

    Scores were assessed daily for 5 days and an average of the five days was reported.

  2. Severity of Nausea

    Time frame: Assessed daily while in hospital requiring PCA.

    Nausea VAS presented to subject daily. Zero minimum "none" to 10 maximum "worse possible". Higher scores represent worse clinical outcome.

    Name of scale "Nausea VAS".

    Scores were assessed daily for 5 days and an average of the five days reported.

  3. Severity of Pain

    Time frame: Assessed by bedside nurse 3 times daily while requiring PCA

    Visual analog scale for pain. Zero "none" minimum to 10 "worse possible" maximum.

    Name of scale "Pain VAS".

    Scores were assessed daily for 5 days and an average of the five days was reported.

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Feb 13, 2012
Registry last updated
Sep 10, 2020

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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