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

This study has been terminated.
(Shortages of study drug, difficulty enrolling patients)
Sponsor:
Information provided by (Responsible Party):
Neil S Bailard, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01430182
First received: September 6, 2011
Last updated: March 3, 2016
Last verified: March 2016
Results First Received: March 3, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain, Postoperative
Interventions: Drug: Methadone
Drug: Morphine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
18 subjects were approached for participation. 1 was a screen failure, yielding 17 subjects who were randomized and received methadone or morphine

Reporting Groups
  Description
Methadone 0.2 mg/kg

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.

Morphine 0.2 mg/kg

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.


Participant Flow:   Overall Study
    Methadone 0.2 mg/kg     Morphine 0.2 mg/kg  
STARTED     9     8  
COMPLETED     9     8  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Methadone 0.2 mg/kg

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.

Morphine 0.2 mg/kg

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 Total of all reporting groups

Baseline Measures
    Methadone 0.2 mg/kg     Morphine 0.2 mg/kg     Total  
Number of Participants  
[units: participants]
  9     8     17  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     8     17  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  31.9  (7.4)     29.3  (10.2)     30.7  (8.6)  
Gender  
[units: participants]
     
Female     2     1     3  
Male     7     7     14  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     7     4     11  
Not Hispanic or Latino     2     4     6  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     9     8     17  



  Outcome Measures

1.  Primary:   Opioid Consumption   [ Time Frame: First 24 hours after discharge from Post-Anesthesia Care Unit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small numbers of subjects analyzed. Shortages of IV methadone prompted closure of trial.


  More Information
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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: Neil Bailard
Organization: Baylor College of Medicine
phone: 713-798-7356
e-mail: bailard@bcm.edu


Publications:

Responsible Party: Neil S Bailard, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01430182     History of Changes
Other Study ID Numbers: H-28734
Study First Received: September 6, 2011
Results First Received: March 3, 2016
Last Updated: March 3, 2016
Health Authority: United States: Institutional Review Board