A Phase 4 interventional study of Ketamine and Placebo in Postoperative Pain, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-22.
Sponsored by Brigham and Women's Hospital · Phase 4, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's enrollment of 64 is below the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Ketamine · Drug: Hydromorphone PCA
Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline).
Drug: Placebo · Drug: Hydromorphone PCA
Intravenous (IV) ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively.
Patients who received ketamine-matching placebo were given saline infusions
Intravenous hydromorphone PCA
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.
Time frame: Participants were followed for the duration of hospital stay, an average of approximately 3 days.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Participants were followed for the duration of hospital stay, an average of approximately 3 days.
| Milestone | Ketamine | Placebo |
|---|---|---|
| Started | 32 | 32 |
| Completed | 29 | 30 |
| Not completed | 3 | 2 |
| Withdrew: Discharged prior to study completion | 2 | 1 |
| Withdrew: Participant opted for morphine pca | 1 | 1 |
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.
| units on a scale | Ketamine | Placebo |
|---|---|---|
| Average Postoperative Pain Score | 6.0 ± 2.2 | 7.3 ± 2.2 |
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.
| units on a scale | Ketamine | Placebo |
|---|---|---|
| Worst Postoperative Pain Score | 8.7 ± 2.0 | 9.0 ± 1.9 |
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.
| units on a scale | Ketamine | Placebo |
|---|---|---|
| Least Postoperative Pain Score | 4.4 ± 3.1 | 5.6 ± 3.0 |
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.
| oral morphine mg equivalents | Ketamine | Placebo |
|---|---|---|
| 24-Hour Postoperative Opioid Use | 726 ± 489 | 770 ± 560 |
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 | Ketamine | Placebo |
|---|---|---|
| Respiratory depression | 0 | 0 |
| Hallucination | 1 | 0 |
| Pruritis | 5 | 2 |
| Sedation | 25 | 24 |
| Nausea | 7 | 5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ketamine | — | 0/27 (0%) | 5/27 (18.5%) |
| Placebo | — | 2/28 (7.1%) | 2/28 (7.1%) |
| Event | Ketamine | Placebo |
|---|---|---|
| Drug administration errorInjury, poisoning and procedural complications | 0/27 | 1/28 |
| Respiratory arrestRespiratory, thoracic and mediastinal disorders | 0/27 | 1/28 |
| Event | Ketamine | Placebo |
|---|---|---|
| PruritisSkin and subcutaneous tissue disorders | 5/27 | 2/28 |
Baseline characteristics are based on the total number of participants who completed the study.
| Age, Continuous(years) | Ketamine | Placebo | Total |
|---|---|---|---|
| Mean | 48.5 ± 11.9 | 55 ± 11.2 | 52.2 ± 11.5 |
| Sex: Female, Male(Participants) | Ketamine | Placebo | Total |
|---|---|---|---|
| Female | 16 | 17 | 33 |
| Male | 13 | 13 | 26 |
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Brigham and Women's Hospital