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Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients

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ClinicalTrials.gov Identifier: NCT01591382
Recruitment Status : Completed
First Posted : May 4, 2012
Results First Posted : March 22, 2017
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Srdjan Nedeljkovic, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE May 1, 2012
First Posted Date  ICMJE May 4, 2012
Results First Submitted Date  ICMJE February 1, 2017
Results First Posted Date  ICMJE March 22, 2017
Last Update Posted Date March 22, 2017
Study Start Date  ICMJE September 2008
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
Average Postoperative Pain Score [ Time Frame: Participants were followed for the duration of hospital stay, an average of approximately 3 days. ]
Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for "worst," "average," and "least" pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average postoperative pain score for each treatment arm is reported.
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
Pain relief [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ]
Evaluate efficacy of ketamine for postop pain control in opioid-dependent patients who receive ketamine in addition to postop patient controlled analgesia with opioids
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
  • Worst Postoperative Pain Score [ Time Frame: Participants were followed for the duration of hospital stay, an average of approximately 3 days. ]
    Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for "worst," "average," and "least" pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average worst postoperative pain score for each treatment arm is reported.
  • Least Postoperative Pain Score [ Time Frame: Participants were followed for the duration of hospital stay, an average of approximately 3 days. ]
    Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for "worst," "average," and "least" pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average least postoperative pain score for each treatment arm is reported.
  • 24-Hour Postoperative Opioid Use [ Time Frame: For 24 hours following surgery ]
    Opioid use is defined as the total milligrams of hydromorphone plus other home or oral opioid used per 24 hours, converted to oral morphine equivalents.
  • Number of Participants With Treatment Related Adverse Events (AEs) [ Time Frame: Participants were followed for the duration of hospital stay, an average of approximately 3 days. ]
    Participants were asked to complete a "Side Effects Checklist" to assess for any unwanted side effects (AEs) of drugs that were administered. The determination of whether or not an AE was treatment related was at the discretion of the Investigator.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients
Official Title  ICMJE Hydromorphone PCA or Hydromorphone PCA With Ketamine for Acute Postoperative Pain Relief in Opioid-Dependent Chronic Pain Patients
Brief Summary Patients who are dependent on opioids often have poor pain relief after major surgery. This study tests the hypothesis that adding intravenous ketamine to a postoperative regimen of intravenous opioids for postoperative pain will improve pain relief in this subset of patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Ketamine
    Intravenous (IV) ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively.
  • Drug: Placebo
    Patients who received ketamine-matching placebo were given saline infusions
  • Drug: Hydromorphone PCA
    Intravenous hydromorphone PCA
Study Arms  ICMJE
  • Active Comparator: Ketamine
    Participants received postoperative hydromorphone patient-controlled analgesia (PCA) and continuous ketamine (0.2 mg/kg/hour). Ketamine is being compared to the use of placebo, in addition to intravenous opioids, for postop pain control in opioid dependent patients who undergo major surgery.
    Interventions:
    • Drug: Ketamine
    • Drug: Hydromorphone PCA
  • Placebo Comparator: Placebo
    Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline).
    Interventions:
    • Drug: Placebo
    • Drug: Hydromorphone PCA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2012)
64
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronic pain > 6 months
  • Long term use of opioids
  • Major surgery

Exclusion Criteria:

  • Use of regional anesthetic techniques
  • No need for intravenous (IV) patient controlled analgesia (PCA) after surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01591382
Other Study ID Numbers  ICMJE 2008P001126
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Srdjan Nedeljkovic, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Srdjan S Nedeljkovic, M.D. Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP