Postoperative PainPhase 3KAPANCT04646694
The Ketamine for Acute Postoperative Analgesia (KAPA) Trial
A Phase 3 study testing Ketamine in people with Postoperative Pain, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Postoperative pain remains an important challenge for both patients and clinicians. Despite advances in pain management techniques, many patients continue to describe their pain as moderate to severe immediately after surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ketamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 17 Nov 2020to 30 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 undergoing multi-level lumbar fusion and decompression
- Planned overnight admission to hospital
Who cannot join
- Patients taking greater than 90 milligram morphine equivalents
- History of substance use disorder
- Previous surgery within six months
- Pre-existing renal or liver impairment
- Chronic benzodiazepine use
- Psychiatric disorder with current/active pharmacologic treatment
- Inability to complete questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative pain remains an important challenge for both patients and clinicians. Despite advances in pain management techniques, many patients continue to describe their pain as moderate to severe immediately after surgery. Poor postoperative pain control is associated with increased morbidity, functional impairment, and higher health care costs. While opioids currently represent the mainstay of treating surgical pain, their use is associated with significant side effects including respiratory depression, delayed recovery of bowel function as well as the potential for long-term use. Therefore, there is an urgent need to find new pain relievers with a safer side effect profiles. One such drug that has been receiving increasing attention is ketamine. Previous studies have focused on using intravenous ketamine postoperatively which requires a monitored setting but have ignored the oral form. By using the oral route of administration, ketamine could potentially be used by patients in a less resource-intensive manner with similar efficacy. Therefore, Investigators propose to conduct the Ketamine for Acute Postoperative Analgesia (KAPA) pilot study to examine the role of oral ketamine in improving recovery after spine surgery.
Read the detailed description
Pain after surgery remains an important challenge for both patients and clinicians. Despite advances in pain management techniques, many patients continue to describe their pain as moderate to severe immediately after surgery. Poor surgical pain control is associated with increased morbidity, functional impairment, and higher health care costs. While opioids currently represent the mainstay of treating surgical pain, their use is associated with significant side effects including respiratory depression, delayed recovery of bowel function as well as the potential for long-term use.
Therefore, there is an urgent need to find new pain relievers with a safer side effect profiles. One such drug that has been receiving increasing attention is ketamine. Previous studies have focused on using intravenous ketamine postoperatively which requires a monitored setting but have ignored the oral form. By using the oral route of administration, ketamine could potentially be used by patients in a less resource-intensive manner with similar efficacy. Therefore, Investigators propose to conduct the Ketamine for Acute Postoperative Analgesia (KAPA) pilot study to examine the role of oral ketamine in improving recovery after spine surgery.
The drug being studied in this trial is called Ketamine. Ketamine was initially developed as a unique anesthetic drug in the 1950's, clinicians later realized that when given in low doses, Ketamine can improve pain control after surgery and other chronic neuropathic conditions. It can be particularly helpful for patients whose pain is not adequately controlled with commonly used pain medications. Ketamine has also found new roles to aid in opioid tapering of subjects with opioid dependence and in the treatment of addiction.
Health Canada has approved Ketamine for medical use in hospital setting as an IV anesthetic agent for surgical procedures. However, there are currently no Health Canada approved oral Ketamine formulations. Although, it should be noted that oral ketamine is routinely used as part of standard order sets at several health institutions across Toronto and Canada.
The use of oral Ketamine in this study is experimental. Experimental means Health Canada has not approved the oral use of Ketamine but they have approved its use in this research study.
This study will look at how effective and safe Ketamine.
If participant decide to participate, the investigator will be in contact with your regular health care provider throughout the time that you are in the study and afterwards, if needed.
Participants are being asked to take part in this research study because they will be having elective spine surgery under general anesthesia and participants may develop pain after surgery.
The usual treatment for established pain after surgery is an approved intravenous opioid, such as hydromorphone, acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs). However, opiates usage carries significant risk of addiction and overdose, particularly with prolonged or increased dosing. Using a combination of medications to treat postoperative pain is quickly becoming more common in an attempt to avoid severe post-operative pain. Because of these limitations, it is important that Investigators look for new options to treat surgical pain.
Approximately 40 people will take part in this study at Toronto Western Hospital/UHN. Investigators expect the study to last for about 12 months.
- Conditions
- Postoperative Pain
- Being tested
- Ketamine, Placebo
- Keywords
- Postoperative, pain, effective, safe, Ketamine, placebo
- 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.
KetamineDrug
Also called Ketamine Group
The use of oral Ketamine in this study is experimental.This study will look at how effective and safe Ketamine.
PlaceboOther
Also called Placebo group
A placebo is given in this study to reduce the chances of believing that pain after surgery is getting better because one is receiving oral Ketamine
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 | Experimental | Patient will receive Ketamine at a dose of 30 mg every eight hours. It will be mixed with apple juice prior to administration and taken orally. Patients will receive Ketamine for three days or nine doses total. Receives: Drug: Ketamine |
| Study group 2 | Placebo comparator | Patient will receive Placebo at a matching dose every eight hours. It will be mixed with apple juice prior to administration and taken orally. Patients will receive Placebo for three days or nine doses total. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery After Surgery
The Quality of Recovery-15 is a self-reported, patient centered outcome metric. The questionnaire has been psychometrically tested and validated. It has been shown to have good content validity, internal consistency and reliability. It captures five domains of recovery after surgery including pain, physical independence, psychological support and emotional state. It can be printed on a single sheet of paper and is easily administered in under three minutes. A change in 8 points on the score has been defined as the minimally important clinical difference in a previous study.
Measured: 30 days
Secondary outcomes (4)
Opioid Use
Opioid use as an inpatient will be determined by examining the medical administration record. During outpatient follow-up phone calls patients will be asked for their average daily opioid use. This will then be converted to a daily morphine equivalent dose.
Measured: 30 days
Pain Intensity
Participants will use a numeric rating scale to rate their pain from 0-10. Patients will be asked to rate the maximum, minimum and average pain intensity over the past 24 hours.
Measured: 30 days
Pain Interference
The impact of pain as measured by interference with daily activities will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference questionnaire.
Measured: 30 days
Mood
Patient Health Questionaire-9 (PHQ-9) is a validated, brief diagnostic and severity measure of depression. It is sensitive to change over time and can track responses to treatment.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start17 Nov 2020
- Primary completion31 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a two arm, randomized controlled trial with a target enrollment of forty patients. Randomization will be performed with a 1:1 allocation with Ketamine or Placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Dinsmore, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646694
- Sponsor's protocol ID
- 20-5064
- Acronym
- KAPA
- Status last verified
- Aug 2023
- First submitted
- 17 Nov 2020
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ketamine for Acute Postoperative Analgesia (KAPA) Trial
- ClinicalTrials.gov ID
- NCT04646694
- Acronym / sponsor ID
- KAPA / 20-5064
- Conditions
- Postoperative Pain
- Keywords
- Postoperative, pain, effective, safe, Ketamine, placebo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative pain remains an important challenge for both patients and clinicians. Despite advances in pain management techniques, many patients continue to describe their pain as moderate to severe immediately after surgery. Poor postoperative pain control is associated with increased morbidity, functional impairment, and higher health care costs. While opioids currently represent the mainstay of treating surgical pain, their use is associated with significant side effects including respiratory depression, delayed recovery of bowel function as well as the potential for long-term use. Therefore, there is an urgent need to find new pain relievers with a safer side effect profiles. One such drug that has been receiving increasing attention is ketamine. Previous studies have focused on using intravenous ketamine postoperatively which requires a monitored setting but have ignored the oral form. By using the oral route of administration, ketamine could potentially be used by patients in a less resource-intensive manner with similar efficacy. Therefore, Investigators propose to conduct the Ketamine for Acute Postoperative Analgesia (KAPA) pilot study to examine the role of oral ketamine in improving recovery after spine surgery.
Detailed description
Pain after surgery remains an important challenge for both patients and clinicians. Despite advances in pain management techniques, many patients continue to describe their pain as moderate to severe immediately after surgery. Poor surgical pain control is associated with increased morbidity, functional impairment, and higher health care costs. While opioids currently represent the mainstay of treating surgical pain, their use is associated with significant side effects including respiratory depression, delayed recovery of bowel function as well as the potential for long-term use.
Therefore, there is an urgent need to find new pain relievers with a safer side effect profiles. One such drug that has been receiving increasing attention is ketamine. Previous studies have focused on using intravenous ketamine postoperatively which requires a monitored setting but have ignored the oral form. By using the oral route of administration, ketamine could potentially be used by patients in a less resource-intensive manner with similar efficacy. Therefore, Investigators propose to conduct the Ketamine for Acute Postoperative Analgesia (KAPA) pilot study to examine the role of oral ketamine in improving recovery after spine surgery.
The drug being studied in this trial is called Ketamine. Ketamine was initially developed as a unique anesthetic drug in the 1950's, clinicians later realized that when given in low doses, Ketamine can improve pain control after surgery and other chronic neuropathic conditions. It can be particularly helpful for patients whose pain is not adequately controlled with commonly used pain medications. Ketamine has also found new roles to aid in opioid tapering of subjects with opioid dependence and in the treatment of addiction.
Health Canada has approved Ketamine for medical use in hospital setting as an IV anesthetic agent for surgical procedures. However, there are currently no Health Canada approved oral Ketamine formulations. Although, it should be noted that oral ketamine is routinely used as part of standard order sets at several health institutions across Toronto and Canada.
The use of oral Ketamine in this study is experimental. Experimental means Health Canada has not approved the oral use of Ketamine but they have approved its use in this research study.
This study will look at how effective and safe Ketamine.
If participant decide to participate, the investigator will be in contact with your regular health care provider throughout the time that you are in the study and afterwards, if needed.
Participants are being asked to take part in this research study because they will be having elective spine surgery under general anesthesia and participants may develop pain after surgery.
The usual treatment for established pain after surgery is an approved intravenous opioid, such as hydromorphone, acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs). However, opiates usage carries significant risk of addiction and overdose, particularly with prolonged or increased dosing. Using a combination of medications to treat postoperative pain is quickly becoming more common in an attempt to avoid severe post-operative pain. Because of these limitations, it is important that Investigators look for new options to treat surgical pain.
Approximately 40 people will take part in this study at Toronto Western Hospital/UHN. Investigators expect the study to last for about 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be a two arm, randomized controlled trial with a target enrollment of forty patients. Randomization will be performed with a 1:1 allocation with Ketamine or Placebo.
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | Experimental | Drug: KetaminePatient will receive Ketamine at a dose of 30 mg every eight hours. It will be mixed with apple juice prior to administration and taken orally. Patients will receive Ketamine for three days or nine doses total. |
| Study group 2 | Placebo comparator | Other: PlaceboPatient will receive Placebo at a matching dose every eight hours. It will be mixed with apple juice prior to administration and taken orally. Patients will receive Placebo for three days or nine doses total. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18-75 undergoing multi-level lumbar fusion and decompression
- Planned overnight admission to hospital
Key exclusion criteria (7 listed)
- Patients taking greater than 90 milligram morphine equivalents
- History of substance use disorder
- Previous surgery within six months
- Pre-existing renal or liver impairment
- Chronic benzodiazepine use
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 |
|---|---|---|
| KetamineAlso: Ketamine GroupThe use of oral Ketamine in this study is experimental.This study will look at how effective and safe Ketamine. | Drug | Study Group 1 |
| PlaceboAlso: Placebo groupA placebo is given in this study to reduce the chances of believing that pain after surgery is getting better because one is receiving oral Ketamine | Other | Study group 2 |
Primary outcome
Recovery After Surgery
Time frame: 30 days
The Quality of Recovery-15 is a self-reported, patient centered outcome metric. The questionnaire has been psychometrically tested and validated. It has been shown to have good content validity, internal consistency and reliability. It captures five domains of recovery after surgery including pain, physical independence, psychological support and emotional state. It can be printed on a single sheet of paper and is easily administered in under three minutes. A change in 8 points on the score has been defined as the minimally important clinical difference in a previous study.
4 secondary outcomes
Opioid Use
Time frame: 30 days
Pain Intensity
Time frame: 30 days
Pain Interference
Time frame: 30 days
Mood
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Michael Dinsmore, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine in people with Postoperative Pain, run by University Health Network, Toronto 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 2 inclusion and 7 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 21 May 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recovery After Surgery (time frame: 30 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 21 May 2024.