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

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ClinicalTrials.gov Identifier: NCT01531439
Recruitment Status : Completed
First Posted : February 13, 2012
Results First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Ben J Pieters, Children's Mercy Hospital Kansas City

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Pain, Postoperative
Postoperative Nausea and Vomiting
Scoliosis
Intervention Drug: Naloxone
Enrollment 84
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
Hide 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
Arm/Group Title Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr Total
Hide 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 Number of Baseline Participants 37 42 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 42 participants 79 participants
<=18 years
37
 100.0%
42
 100.0%
79
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 42 participants 79 participants
Female
34
  91.9%
37
  88.1%
71
  89.9%
Male
3
   8.1%
5
  11.9%
8
  10.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants 42 participants 79 participants
37 41 78
1.Primary Outcome
Title Number of Hours Until Tolerating Oral Intake
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
Hide 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

Overall Number of Participants Analyzed 37 42
Median (Inter-Quartile Range)
Unit of Measure: hours
25.9
(19.4 to 29.8)
25.0
(18.8 to 28.0)
2.Secondary Outcome
Title Severity of Itching
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
Hide 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

Overall Number of Participants Analyzed 37 42
Median (Inter-Quartile Range)
Unit of Measure: score on a scale, averaged
2.1
(0.6 to 3.7)
1.9
(0.6 to 3.7)
3.Secondary Outcome
Title Severity of Nausea
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
Hide 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

Overall Number of Participants Analyzed 37 42
Median (Inter-Quartile Range)
Unit of Measure: score on a scale, averaged
2.0
(0.5 to 3.2)
1.2
(0.3 to 2.8)
4.Secondary Outcome
Title Severity of Pain
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
Hide 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

Overall Number of Participants Analyzed 37 42
Median (Inter-Quartile Range)
Unit of Measure: units on a scale, averaged
3.7
(2.7 to 5.1)
4.1
(3.0 to 5.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
Hide 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 (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/42 (0.00%) 
Hide Serious Adverse Events
Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/42 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Naloxone Infusion 0.5 mcg/kg/hr Naloxone 2.5 mcg/kg/hr
Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/42 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr Ben Pieters
Organization: Children's Mercy Hospital
Phone: 816-234-3464
EMail: bjpieters@cmh.edu
Layout table for additonal information
Responsible Party: Ben J Pieters, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01531439    
Other Study ID Numbers: 11 04-059
First Submitted: June 20, 2011
First Posted: February 13, 2012
Results First Submitted: August 20, 2020
Results First Posted: September 10, 2020
Last Update Posted: September 10, 2020