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Effect of Ketamine on Opioid-Induced Hyperalgesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00833755
First received: January 29, 2009
Last updated: November 17, 2016
Last verified: November 2016
Results First Received: September 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Health Services Research
Conditions: Pain
Chronic Pain
Hyperalgesia
Interventions: Drug: Ketamine
Drug: Placebos

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Opioid - Ketamine Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
Opioid - Placebos Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
Non-opioid - Ketamine This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
Non-opioid - Placebos This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.

Participant Flow:   Overall Study
    Opioid - Ketamine   Opioid - Placebos   Non-opioid - Ketamine   Non-opioid - Placebos
STARTED   16   18   22   23 
COMPLETED   12   13   20   17 
NOT COMPLETED   4   5   2   6 
Physician Decision                4                4                2                6 
Subject had scheduling issues                0                1                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
Opioid - Ketamine Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
Opioid - Placebos Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
Non-opioid - Ketamine This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
Non-opioid - Placebos This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
Total Total of all reporting groups

Baseline Measures
   Opioid - Ketamine   Opioid - Placebos   Non-opioid - Ketamine   Non-opioid - Placebos   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   18   22   23   79 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      16 100.0%      18 100.0%      22 100.0%      23 100.0%      79 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Gender 
[Units: Participants]
Count of Participants
         
Female      10  62.5%      8  44.4%      15  68.2%      13  56.5%      46  58.2% 
Male      6  37.5%      10  55.6%      7  31.8%      10  43.5%      33  41.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Temperature of Pain Threshold   [ Time Frame: Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1 ]

2.  Primary:   Change in Temperature of Pain Tolerance   [ Time Frame: Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1 ]

3.  Primary:   Change in Duration of Supra-threshold Pain Tolerance   [ Time Frame: Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1 ]


  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
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  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: Dr. Jianren Mao
Organization: Massachusetts General Hospital
phone: 6177246102
e-mail: mghpainresearch@partners.org



Responsible Party: Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00833755     History of Changes
Other Study ID Numbers: 2008P 000879
Study First Received: January 29, 2009
Results First Received: September 20, 2016
Last Updated: November 17, 2016