Back to resultsEfficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Placebo
Hydromorphone PCA
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Ketamine, Postoperative pain, Opioid dependent patients, Acute pain control
Eligibility Criteria
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
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ketamine
Placebo
Arm Description
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.
Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline).
Outcomes
Primary Outcome Measures
Average Postoperative Pain Score
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.
Secondary Outcome Measures
Worst Postoperative Pain Score
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
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
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)
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.
Full Information
NCT ID
NCT01591382
First Posted
May 1, 2012
Last Updated
February 1, 2017
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01591382
Brief Title
Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients
Official Title
Hydromorphone PCA or Hydromorphone PCA With Ketamine for Acute Postoperative Pain Relief in Opioid-Dependent Chronic Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Ketamine, Postoperative pain, Opioid dependent patients, Acute pain control
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline).
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Intravenous (IV) ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients who received ketamine-matching placebo were given saline infusions
Intervention Type
Drug
Intervention Name(s)
Hydromorphone PCA
Intervention Description
Intravenous hydromorphone PCA
Primary Outcome Measure Information:
Title
Average Postoperative Pain Score
Description
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.
Time Frame
Participants were followed for the duration of hospital stay, an average of approximately 3 days.
Secondary Outcome Measure Information:
Title
Worst Postoperative Pain Score
Description
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.
Time Frame
Participants were followed for the duration of hospital stay, an average of approximately 3 days.
Title
Least Postoperative Pain Score
Description
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.
Time Frame
Participants were followed for the duration of hospital stay, an average of approximately 3 days.
Title
24-Hour Postoperative Opioid Use
Description
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.
Time Frame
For 24 hours following surgery
Title
Number of Participants With Treatment Related Adverse Events (AEs)
Description
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.
Time Frame
Participants were followed for the duration of hospital stay, an average of approximately 3 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srdjan S Nedeljkovic, M.D.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
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Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients
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