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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Active Comparator | 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. |
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| Placebo | Placebo Comparator | Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Intravenous (IV) ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants were followed for the duration of hospital stay, an average of approximately 3 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Srdjan S Nedeljkovic, M.D. | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine | Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively. |
| FG001 | Placebo | Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline characteristics are based on the total number of participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine | Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively. |
| BG001 | Placebo | Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants who completed the study. | Posted | Mean | Standard Deviation | units on a scale | Participants were followed for the duration of hospital stay, an average of approximately 3 days. |
|
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Adverse events are reported for all randomized participants who completed the study and also completed the Side Effects Checklist.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketamine | Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug administration error | Injury, poisoning and procedural complications |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritis | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Srdjan S. Nedeljkovic | Brigham and Women's Hospital | snedeljkovic@partners.org |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo |
| Drug |
Patients who received ketamine-matching placebo were given saline infusions |
|
| Hydromorphone PCA | Drug | Intravenous hydromorphone PCA |
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| Participants were followed for the duration of hospital stay, an average of approximately 3 days. |
| 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. | Participants were followed for the duration of hospital stay, an average of approximately 3 days. |
| 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. | For 24 hours following surgery |
| 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. | Participants were followed for the duration of hospital stay, an average of approximately 3 days. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Placebo |
Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively. |
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|
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| Secondary | 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. | All randomized participants who completed the study. | Posted | Mean | Standard Deviation | units on a scale | Participants were followed for the duration of hospital stay, an average of approximately 3 days. |
|
|
|
|
| Secondary | 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. | All randomized participants who completed the study. | Posted | Mean | Standard Deviation | units on a scale | Participants were followed for the duration of hospital stay, an average of approximately 3 days. |
|
|
|
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| Secondary | 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. | All randomized participants who completed the study. | Posted | Mean | Standard Deviation | oral morphine mg equivalents | For 24 hours following surgery |
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| Secondary | 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. | All randomized participants who completed the study and also completed the Side Effects Checklist. | Posted | Number | participants | Participants were followed for the duration of hospital stay, an average of approximately 3 days. |
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|
|
| 0 |
| 27 |
| 5 |
| 27 |
| EG001 | Placebo | Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively. | 2 | 28 | 2 | 28 |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| Pruritis |
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| Sedation |
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| Nausea |
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