Pain, PostoperativePhase 4NCT02925858
Effect of Ketamine on Analgesia Post-Cardiac Surgery
A Phase 4 study testing Normal Saline Flush, 0.9% Injectable Solution_#1 and Ketamine Hydrochloride in people with Pain, Postoperative, run by Jewish General Hospital at 1 site in Canada.
Trial summary
Randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative infusion of intravenous Ketamine on the quantity of opioid consumed postoperatively in coronary artery bypass surgery patients receiving a median sternotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Normal Saline Flush, 0.9% Injectable Solution_#1 and Ketamine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 28 Aug 2017to 27 Nov 2018
- 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
- Patients 18 years of age or older coming for coronary artery bypass surgery with a left ventricular ejection fraction over 50% and able to consent prior to surgery
Who cannot join
- Minimally invasive cardiac surgery
- Preoperative opioid use
- Preoperative hepatic or renal dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study: The Effect of Intraoperative Ketamine on Analgesia Post-Cardiac Surgery and Prevention of Chronic Pain
Randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative infusion of intravenous Ketamine on the quantity of opioid consumed postoperatively in coronary artery bypass surgery patients receiving a median sternotomy.
Read the detailed description
This is a randomized, controlled, double-blind pilot study to determine the effectiveness of intraoperative Ketamine administration on pain after coronary artery bypass surgery. Patients will be randomized to receive ketamine or saline prior to incision, with a continuous infusion throughout surgery. Opioid dose administered in the first 48 hours will then be documented as the primary outcome
- Conditions
- Pain, Postoperative
- Being tested
- Normal Saline Flush, 0.9% Injectable Solution_#1, Ketamine Hydrochloride
- Keywords
- Ketamine, Cardiac surgery, Pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline Flush, 0.9% Injectable Solution_#1Drug
Normal saline infusion mimicking infusion rate of ketamine for a given weight
Ketamine HydrochlorideDrug
Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intraoperative infusion of ketamine Receives: Drug: Ketamine Hydrochloride |
| Control | Placebo comparator | Control group receiving a saline infusion Receives: Drug: Normal Saline Flush, 0.9% Injectable Solution_#1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of Opioids Used in the First 48 Hours Postoperatively
Opioids used, in Dilaudid equivalents
Measured: First 48 hours after arrival to the ICU
Secondary outcomes (9)
Quantity of Opioids Used
Quantity in mg
Measured: 24 hours postoperatively
Pain Scores (Visual Analog Scale)
Average Pain Score as reported by the patient on a numeric scale ranging from 0 (no pain) to a maximum of 10 points (worst pain imaginable)
Measured: Postoperative days 2
Postoperative Nausea and Vomiting
Whether or not the patient suffered from nausea and vomiting after surgery which required treatment
Measured: 48 hours after ICU arrival
Intensive Care Unit Length of Stay
Number of days spent in the intensive care unit
Measured: 1 day - 2 weeks
Hospital Length of Stay
number of days spent in the hospital, starting from the day of surgery
Measured: 5 days - 2 weeks
Time to Extubation
Number of minutes from the time of ICU arrival to extubation
Measured: 4 hours - 2 weeks
Delirium
Delirium as assessed by a positive CAM-ICU score during the ICU stay
Measured: ICU stay
Time to Mobilization
Time from ICU arrival until patient able to mobilize to chair, measured in hours
Measured: During hospital stay
Time to Ambulation
Time from ICU arrival until patient able to ambulate, measured in hours
Measured: 1 week postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start28 Aug 2017
- Primary completion1 Nov 2018
- Study completion27 Nov 2018
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 Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Cameron, Jewish General Hospital
- Investigators
- Matthew Cameron, MD, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925858
- Sponsor's protocol ID
- 16-289
- Status last verified
- Aug 2019
- First submitted
- 4 Oct 2016
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will provide all uncoded data
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: The Effect of Intraoperative Ketamine on Analgesia Post-Cardiac Surgery and Prevention of Chronic Pain
- ClinicalTrials.gov ID
- NCT02925858
- Acronym / sponsor ID
- 16-289
- Conditions
- Pain, Postoperative
- Keywords
- Ketamine, Cardiac surgery, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative infusion of intravenous Ketamine on the quantity of opioid consumed postoperatively in coronary artery bypass surgery patients receiving a median sternotomy.
Detailed description
This is a randomized, controlled, double-blind pilot study to determine the effectiveness of intraoperative Ketamine administration on pain after coronary artery bypass surgery. Patients will be randomized to receive ketamine or saline prior to incision, with a continuous infusion throughout surgery. Opioid dose administered in the first 48 hours will then be documented as the primary outcome
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Ketamine HydrochlorideIntraoperative infusion of ketamine |
| Control | Placebo comparator | Drug: Normal Saline Flush, 0.9% Injectable Solution_#1Control group receiving a saline infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years of age or older coming for coronary artery bypass surgery with a left ventricular ejection fraction over 50% and able to consent prior to surgery
Key exclusion criteria (3 listed)
- Minimally invasive cardiac surgery
- Preoperative opioid use
- Preoperative hepatic or renal dysfunction
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 |
|---|---|---|
| Normal Saline Flush, 0.9% Injectable Solution_#1Normal saline infusion mimicking infusion rate of ketamine for a given weight | Drug | Control |
| Ketamine HydrochlorideKetamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery) | Drug | Intervention |
Primary outcome
Quantity of Opioids Used in the First 48 Hours Postoperatively
Time frame: First 48 hours after arrival to the ICU
Opioids used, in Dilaudid equivalents
9 secondary outcomes
Quantity of Opioids Used
Time frame: 24 hours postoperatively
Pain Scores (Visual Analog Scale)
Time frame: Postoperative days 2
Postoperative Nausea and Vomiting
Time frame: 48 hours after ICU arrival
Intensive Care Unit Length of Stay
Time frame: 1 day - 2 weeks
Hospital Length of Stay
Time frame: 5 days - 2 weeks
Time to Extubation
Time frame: 4 hours - 2 weeks
Delirium
Time frame: ICU stay
Time to Mobilization
Time frame: During hospital stay
Time to Ambulation
Time frame: 1 week postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Will provide all uncoded data
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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.
Matthew Cameron, MD principal investigator
Jewish General 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 Normal Saline Flush, 0.9% Injectable Solution_#1 and Ketamine Hydrochloride in people with Pain, Postoperative, run by Jewish General Hospital at 1 site in Canada.
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 1 inclusion and 3 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 6 Sep 2019. 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 Canada. 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 6 Sep 2019). 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?
Quantity of Opioids Used in the First 48 Hours Postoperatively (time frame: First 48 hours after arrival to the ICU). 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 6 Sep 2019.