Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
N/A |
Detailed 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Naloxone infusion 0.5 mcg/kg/hr
|
Drug: Naloxone
Naloxone infusion 0.5 mcg/kg/hr
Other Names:
|
Experimental: Naloxone 2.5 mcg/kg/hr Naloxone infusion 2.5 mcg/kg/hr |
Drug: Naloxone
Naloxone infusion 2.5 mcg/kg/hr
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Hours Until Tolerating Oral Intake [Assessed daily in hospital while in hospital until taking orals, average 4 days.]
Defined as time when awakening after surgery until tolerating orals.
Secondary Outcome Measures
- Severity of Itching [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.
- Severity of Nausea [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.
- Severity of Pain [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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Children's Mercy Hospital | Kansas City | Missouri | United States | 64108 |
Sponsors and Collaborators
- Children's Mercy Hospital Kansas City
Investigators
- Principal Investigator: Benjamin J. Pieters, DO, Children's Mercy Hospital Kansas City
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 11 04-059
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Naloxone Infusion 0.5 mcg/kg/hr | Naloxone 2.5 mcg/kg/hr |
---|---|---|
Arm/Group Description | Naloxone: Naloxone infusion 0.5 mcg/kg/hr | Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr |
Period Title: Overall Study | ||
STARTED | 41 | 43 |
COMPLETED | 37 | 42 |
NOT COMPLETED | 4 | 1 |
Baseline Characteristics
Arm/Group Title | Naloxone Infusion 0.5 mcg/kg/hr | Naloxone 2.5 mcg/kg/hr | Total |
---|---|---|---|
Arm/Group Description | Naloxone: Naloxone infusion 0.5 mcg/kg/hr | Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr | Total of all reporting groups |
Overall Participants | 37 | 42 | 79 |
Age (Count of Participants) | |||
<=18 years |
37
100%
|
42
100%
|
79
100%
|
Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
Sex: Female, Male (Count of Participants) | |||
Female |
34
91.9%
|
37
88.1%
|
71
89.9%
|
Male |
3
8.1%
|
5
11.9%
|
8
10.1%
|
Region of Enrollment (participants) [Number] | |||
United States |
37
100%
|
41
97.6%
|
78
98.7%
|
Outcome Measures
Title | Number of Hours Until Tolerating Oral Intake |
---|---|
Description | Defined as time when awakening after surgery until tolerating orals. |
Time Frame | Assessed daily in hospital while in hospital until taking orals, average 4 days. |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Naloxone Infusion 0.5 mcg/kg/hr | Naloxone 2.5 mcg/kg/hr |
---|---|---|
Arm/Group Description | Naloxone: Naloxone infusion 0.5 mcg/kg/hr | Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr |
Measure Participants | 37 | 42 |
Median (Inter-Quartile Range) [hours] |
25.9
|
25.0
|
Title | Severity of Itching |
---|---|
Description | 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. |
Time Frame | Assessed daily while in hospital requiring PCA |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Naloxone Infusion 0.5 mcg/kg/hr | Naloxone 2.5 mcg/kg/hr |
---|---|---|
Arm/Group Description | Naloxone: Naloxone infusion 0.5 mcg/kg/hr | Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr |
Measure Participants | 37 | 42 |
Median (Inter-Quartile Range) [score on a scale, averaged] |
2.1
|
1.9
|
Title | Severity of Nausea |
---|---|
Description | 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. |
Time Frame | Assessed daily while in hospital requiring PCA. |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Naloxone Infusion 0.5 mcg/kg/hr | Naloxone 2.5 mcg/kg/hr |
---|---|---|
Arm/Group Description | Naloxone: Naloxone infusion 0.5 mcg/kg/hr | Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr |
Measure Participants | 37 | 42 |
Median (Inter-Quartile Range) [score on a scale, averaged] |
2.0
|
1.2
|
Title | Severity of Pain |
---|---|
Description | 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. |
Time Frame | Assessed by bedside nurse 3 times daily while requiring PCA |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Naloxone Infusion 0.5 mcg/kg/hr | Naloxone 2.5 mcg/kg/hr |
---|---|---|
Arm/Group Description | Naloxone: Naloxone infusion 0.5 mcg/kg/hr | Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr |
Measure Participants | 37 | 42 |
Median (Inter-Quartile Range) [units on a scale, averaged] |
3.7
|
4.1
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Naloxone Infusion 0.5 mcg/kg/hr | Naloxone 2.5 mcg/kg/hr | ||
Arm/Group Description | Naloxone: Naloxone infusion 0.5 mcg/kg/hr | Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr | ||
All Cause Mortality |
||||
Naloxone Infusion 0.5 mcg/kg/hr | Naloxone 2.5 mcg/kg/hr | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/37 (0%) | 0/42 (0%) | ||
Serious Adverse Events |
||||
Naloxone Infusion 0.5 mcg/kg/hr | Naloxone 2.5 mcg/kg/hr | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/37 (0%) | 0/42 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Naloxone Infusion 0.5 mcg/kg/hr | Naloxone 2.5 mcg/kg/hr | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/37 (0%) | 0/42 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr Ben Pieters |
---|---|
Organization | Children's Mercy Hospital |
Phone | 816-234-3464 |
bjpieters@cmh.edu |
- 11 04-059