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Methadone Versus Morphine for Orthopedic Surgery Patients

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ClinicalTrials.gov Identifier: NCT00892606
Recruitment Status : Completed
First Posted : May 4, 2009
Results First Posted : May 17, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
University of Louisville

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Fracture
Pain, Postoperative
Interventions Drug: Methadone
Drug: Morphine
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Methadone Control
Hide Arm/Group Description

Patients will receive 0.2 mg/kg of methadone IV immediately after intubation

Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation

Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation

Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation

Period Title: Overall Study
Started 38 37
Completed 33 33
Not Completed 5 4
Arm/Group Title Methadone Control Total
Hide Arm/Group Description Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine, and 0.2 mg/kg of methadone IV immediately after intubation Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine, and 0.2 mg/kg morphine Total of all reporting groups
Overall Number of Baseline Participants 38 37 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 37 participants 75 participants
37  (13) 35  (12) 36  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 37 participants 75 participants
Female
7
  18.4%
10
  27.0%
17
  22.7%
Male
31
  81.6%
27
  73.0%
58
  77.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants 37 participants 75 participants
38 37 75
1.Primary Outcome
Title Opioid Consumption During the 48 Hours After Surgery
Hide Description The amount of opioid required for postoperative pain relief
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methadone Control
Hide Arm/Group Description:

Patients will receive 0.2 mg/kg of methadone IV immediately after intubation

Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation

Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation

Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation

Overall Number of Participants Analyzed 33 33
Mean (Standard Deviation)
Unit of Measure: mg
51  (19) 87  (40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0072
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Post Operative Nausea and Vomiting
Hide Description rates subjects experienced PONV
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methadone Control
Hide Arm/Group Description:

Patients will receive 0.2 mg/kg of methadone IV immediately after intubation

Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation

Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation

Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation

Overall Number of Participants Analyzed 33 33
Measure Type: Count of Participants
Unit of Measure: Participants
9
  27.3%
3
   9.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Visual Pain Score
Hide Description Patients rated their pain with the numerical VPS from 0 to 10, with 10 being the worst pain possible and 0 being no pain
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methadone Control
Hide Arm/Group Description:

Patients will receive 0.2 mg/kg of methadone IV immediately after intubation

Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation

Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation

Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation

Overall Number of Participants Analyzed 33 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
5  (3) 6  (2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0146
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methadone Control
Hide Arm/Group Description

Patients will receive 0.2 mg/kg of methadone IV immediately after intubation

Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation

Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation

Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation

All-Cause Mortality
Methadone Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Hide Serious Adverse Events
Methadone Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Methadone Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nancy Alsip
Organization: University Louisville
Phone: 502-852-2905
EMail: nlalsi01@exchange.louisville.edu
Layout table for additonal information
Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00892606    
Other Study ID Numbers: UofL IRB # 08.0200
First Submitted: April 30, 2009
First Posted: May 4, 2009
Results First Submitted: April 6, 2017
Results First Posted: May 17, 2017
Last Update Posted: June 14, 2017