Postoperative PainPhase 4NCT01591382
Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients
A Phase 4 study testing Ketamine and Hydromorphone PCA in people with Postoperative Pain, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ketamine and Hydromorphone PCA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pain > 6 months
- Long term use of opioids
- Major surgery
Who cannot join
- Use of regional anesthetic techniques
- No need for intravenous (IV) patient controlled analgesia (PCA) after surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Hydromorphone PCA or Hydromorphone PCA With Ketamine for Acute Postoperative Pain Relief in Opioid-Dependent Chronic Pain Patients
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.
- Conditions
- Postoperative Pain
- Being tested
- Ketamine, Placebo, Hydromorphone PCA
- Keywords
- Ketamine, Postoperative pain, Opioid dependent patients, Acute pain control
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Intravenous (IV) ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively.
PlaceboDrug
Patients who received ketamine-matching placebo were given saline infusions
Hydromorphone PCADrug
Intravenous hydromorphone PCA
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ketamine; Drug: Hydromorphone PCA |
| Placebo | Placebo comparator | Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline). Receives: Drug: Placebo; Drug: Hydromorphone PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants were followed for the duration of hospital stay, an average of approximately 3 days.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Participants were followed for the duration of hospital stay, an average of approximately 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startSep 2008
- Primary completionJun 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srdjan Nedeljkovic, Brigham and Women's Hospital
- Investigators
- Srdjan S Nedeljkovic, M.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591382
- Sponsor's protocol ID
- 2008P001126
- Status last verified
- Feb 2017
- First submitted
- 1 May 2012
- Last updated
- 22 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydromorphone PCA or Hydromorphone PCA With Ketamine for Acute Postoperative Pain Relief in Opioid-Dependent Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT01591382
- Acronym / sponsor ID
- 2008P001126
- Conditions
- Postoperative Pain
- Keywords
- Ketamine, Postoperative pain, Opioid dependent patients, Acute pain control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 4 May 2012 (estimated)
- Results
- Posted 22 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Active comparator | Drug: Ketamine, Drug: Hydromorphone PCAParticipants 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. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Hydromorphone PCAParticipants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic pain > 6 months
- Long term use of opioids
- Major surgery
Key exclusion criteria (2 listed)
- Use of regional anesthetic techniques
- No need for intravenous (IV) patient controlled analgesia (PCA) after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineIntravenous (IV) ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively. | Drug | Ketamine |
| PlaceboPatients who received ketamine-matching placebo were given saline infusions | Drug | Placebo |
| Hydromorphone PCAIntravenous hydromorphone PCA | Drug | Ketamine, Placebo |
Primary outcome
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.
4 secondary outcomes
Worst Postoperative Pain Score
Time frame: Participants were followed for the duration of hospital stay, an average of approximately 3 days.
Least Postoperative Pain Score
Time frame: Participants were followed for the duration of hospital stay, an average of approximately 3 days.
24-Hour Postoperative Opioid Use
Time frame: For 24 hours following surgery
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srdjan S Nedeljkovic, M.D. principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Hydromorphone PCA in people with Postoperative Pain, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Postoperative Pain Score (time frame: Participants were followed for the duration of hospital stay, an average of approximately 3 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.