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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531439
• Other study ID #: 11 04-059
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: December 1, 2016

Study information

• Verified date: September 2020
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 1, 2016
• Est. primary completion date: May 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Scoliosis
• Vomiting

Intervention

Drug:
• Naloxone
Naloxone infusion 0.5 mcg/kg/hr
• Naloxone
Naloxone infusion 2.5 mcg/kg/hr

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Hours Until Tolerating Oral Intake	Defined as time when awakening after surgery until tolerating orals.	Assessed daily in hospital while in hospital until taking orals, average 4 days.
Secondary	Severity of Itching	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.	Assessed daily while in hospital requiring PCA
Secondary	Severity of Nausea	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.	Assessed daily while in hospital requiring PCA.
Secondary	Severity of Pain	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.	Assessed by bedside nurse 3 times daily while requiring PCA