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Intraoperative Methadone vs Morphine for Postoperative Pain Control in Patients Undergoing Surgery of the Tibia

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ClinicalTrials.gov Identifier: NCT01430182
Recruitment Status : Terminated (Shortages of study drug, difficulty enrolling patients)
First Posted : September 8, 2011
Results First Posted : April 4, 2016
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Neil S Bailard, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain, Postoperative
Interventions Drug: Methadone
Drug: Morphine
Enrollment 17
Recruitment Details Subjects were inpatients in Ben Taub General Hospital, a General and Teaching Hospital in Houston, Texas. Subjects were enrolled from October 2011 through May 2013.
Pre-assignment Details 18 subjects were approached for participation. 1 was a screen failure, yielding 17 subjects who were randomized and received methadone or morphine
Arm/Group Title Methadone 0.2 mg/kg Morphine 0.2 mg/kg
Hide Arm/Group Description

0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.

Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.

0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.

Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.

Period Title: Overall Study
Started 9 8
Completed 9 8
Not Completed 0 0
Arm/Group Title Methadone 0.2 mg/kg Morphine 0.2 mg/kg Total
Hide Arm/Group Description

0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.

Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.

0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.

Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.

Total of all reporting groups
Overall Number of Baseline Participants 9 8 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 17 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
8
 100.0%
17
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 8 participants 17 participants
31.9  (7.4) 29.3  (10.2) 30.7  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 17 participants
Female
2
  22.2%
1
  12.5%
3
  17.6%
Male
7
  77.8%
7
  87.5%
14
  82.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 17 participants
Hispanic or Latino
7
  77.8%
4
  50.0%
11
  64.7%
Not Hispanic or Latino
2
  22.2%
4
  50.0%
6
  35.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 8 participants 17 participants
9 8 17
1.Primary Outcome
Title Opioid Consumption
Hide Description Number of morphine equivalents used by subject during first 24 hours after discharge from Post-Anesthesia Care Unit
Time Frame First 24 hours after discharge from Post-Anesthesia Care Unit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methadone 0.2 mg/kg Morphine 0.2 mg/kg
Hide Arm/Group Description:

0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.

Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.

0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.

Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.

Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: mg of morphine IV equivalents
50.9  (38.7) 37.5  (15.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone 0.2 mg/kg, Morphine 0.2 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method t-test, 1 sided
Comments unpaired
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methadone 0.2 mg/kg Morphine 0.2 mg/kg
Hide Arm/Group Description

0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.

Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.

0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.

Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.

All-Cause Mortality
Methadone 0.2 mg/kg Morphine 0.2 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Methadone 0.2 mg/kg Morphine 0.2 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/8 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Methadone 0.2 mg/kg Morphine 0.2 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/9 (11.11%)      0/8 (0.00%)    
General disorders     
Excessive sedation or excessive somnolence  1/9 (11.11%)  1 0/8 (0.00%)  0
Early termination leading to small numbers of subjects analyzed. Shortages of IV methadone prompted closure of trial.
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: Neil Bailard
Organization: Baylor College of Medicine
Phone: 713-798-7356
EMail: bailard@bcm.edu
Layout table for additonal information
Responsible Party: Neil S Bailard, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01430182    
Other Study ID Numbers: H-28734
First Submitted: September 6, 2011
First Posted: September 8, 2011
Results First Submitted: March 3, 2016
Results First Posted: April 4, 2016
Last Update Posted: April 4, 2016