Pain, PostoperativeNCT04701008
Efficacy of Ketamine in Post Anesthesia Recovery Room
An observational study of Pain, Postoperative and Ketamine Adverse Reaction, run by University of Alberta at 1 site in Canada.
Trial summary
Observational study to assess efficacy of IV ketamine bolus when used in the post anesthesia recovery unit for uncontrolled pain despite use of opioids. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Ketamine Adverse Reaction, Pain, Refractory
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- How many people
- 143 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2020to 28 May 2021
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The following patients will be identified and recruited at the post-anesthesia care unit: Adult patients undergoing non-cardiac surgery at University of Alberta Hospital meeting the following criteria: 1. age ≥ 18 2. significant pain despite narcotics used in post anesthesia care unit 3. ketamine ordered by attending anesthesiologist
Who may be able to join
- Adult patients undergoing non cardiac surgery at University of Alberta Hospital meeting the following criteria:
- age ≥ 18
- significant pain despite narcotics used in post-anesthesia care unit
- ketamine ordered by attending anesthesiologist
Who cannot join
- Patient refusal to receive ketamine
- Patients undergoing cardiac surgery
- Patients who received no narcotics
- Contra-indication to receiving ketamine (determined by attending anesthesiologist)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of the Efficacy of Ketamine for Rescue Analgesia in the Post Anesthesia Recovery Room
Observational study to assess efficacy of IV ketamine bolus when used in the post anesthesia recovery unit for uncontrolled pain despite use of opioids.
Read the detailed description
In this observational study, the investigators will monitor all patients with significant pain after any non-cardiac surgical intervention at the University of Alberta Hospital.
After receiving an adequate dose of potent opioids (hydromorphone, morphine), the participants will receive up to 0,2-0,25 mg/kg IV ketamine bolus. In our center these boluses are given with 10-20mg increments.
The adequate dose of opioids will be determined by the attending anesthesiologist, depending on what patients received intraoperatively and on their comorbidities.
Pain scores will be assessed before and after administration of this drug. The incidence of any side effect after ketamine administration will be documented.
- Conditions
- Pain, Postoperative, Ketamine Adverse Reaction, Pain, Refractory, Pain, Intractable, Pain, Acute
- Being tested
- Ketamine
- Keywords
- pain score reduction, reduction in pain scores, post-operative pain, ketamine use in recovery room, recovery room, ketamine recovery, ketamine rescue
- Medical subject headings
- Pain, Postoperative, Pain, Intractable, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
IV ketamine - 10mg bolus may be repeated repeated 2-3 times depending on clinical judgement
| Study group | Role | What they receive |
|---|---|---|
| Patients with significative post-operative pain despite | Patients with significant pain despite receiving narcotics in PACU will receive a bolus dose of IV ketamine to assess its efficacy for pain score reduction. Bolus doses are given by 10mg IV increments, to reach approximate dose of 0,25mg/kg. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain score after ketamine use in PACU
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is what is used most often in our recovery room for pain assessment. A score of 0/10 means no pain, and 10/10 means worst pain.
Measured: in the immediate post-operative period in recovery room
Secondary outcomes (1)
Incidence of side effects after ketamine use
Measured: in the immediate post-operative period in recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Sep 2020
- Primary completion28 May 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701008
- Sponsor's protocol ID
- Pro00102967
- Status last verified
- Jul 2022
- First submitted
- 5 Jan 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brinck EC, Tiippana E, Heesen M, Bell RF, Straube S, Moore RA, Kontinen V. Perioperative intravenous ketamine for acute postoperative pain in adults. Cochrane Database Syst Rev. 2018 Dec 20;12(12):CD012033. doi: 10.1002/14651858.CD012033.pub4.
PubMed 30570761Gillies A, Lindholm D, Angliss M, Orr A. The use of ketamine as rescue analgesia in the recovery room following morphine administration--a double-blind randomised controlled trial in postoperative patients. Anaesth Intensive Care. 2007 Apr;35(2):199-203.
PubMed 17444308Weinbroum AA. A single small dose of postoperative ketamine provides rapid and sustained improvement in morphine analgesia in the presence of morphine-resistant pain. Anesth Analg. 2003 Mar;96(3):789-795. doi: 10.1213/01.ANE.0000048088.17761.B4.
PubMed 12598264
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Efficacy of Ketamine for Rescue Analgesia in the Post Anesthesia Recovery Room
- ClinicalTrials.gov ID
- NCT04701008
- Acronym / sponsor ID
- Pro00102967
- Conditions
- Pain, Postoperative, Ketamine Adverse Reaction, Pain, Refractory, Pain, Intractable, Pain, Acute
- Keywords
- pain score reduction, reduction in pain scores, post-operative pain, ketamine use in recovery room, recovery room, ketamine recovery, ketamine rescue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 8 Jan 2021 (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.
Observational study to assess efficacy of IV ketamine bolus when used in the post anesthesia recovery unit for uncontrolled pain despite use of opioids.
Detailed description
In this observational study, the investigators will monitor all patients with significant pain after any non-cardiac surgical intervention at the University of Alberta Hospital.
After receiving an adequate dose of potent opioids (hydromorphone, morphine), the participants will receive up to 0,2-0,25 mg/kg IV ketamine bolus. In our center these boluses are given with 10-20mg increments.
The adequate dose of opioids will be determined by the attending anesthesiologist, depending on what patients received intraoperatively and on their comorbidities.
Pain scores will be assessed before and after administration of this drug. The incidence of any side effect after ketamine administration will be documented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with significative post-operative pain despite | – | Drug: KetaminePatients with significant pain despite receiving narcotics in PACU will receive a bolus dose of IV ketamine to assess its efficacy for pain score reduction. Bolus doses are given by 10mg IV increments, to reach approximate dose of 0,25mg/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The following patients will be identified and recruited at the post-anesthesia care unit: Adult patients undergoing non-cardiac surgery at University of Alberta Hospital meeting the following criteria: 1. age ≥ 18 2. significant pain despite narcotics used in post anesthesia care unit 3. ketamine ordered by attending anesthesiologist
Key inclusion criteria (4 listed)
- Adult patients undergoing non cardiac surgery at University of Alberta Hospital meeting the following criteria:
- age ≥ 18
- significant pain despite narcotics used in post-anesthesia care unit
- ketamine ordered by attending anesthesiologist
Key exclusion criteria (4 listed)
- Patient refusal to receive ketamine
- Patients undergoing cardiac surgery
- Patients who received no narcotics
- Contra-indication to receiving ketamine (determined by attending anesthesiologist)
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 |
|---|---|---|
| KetamineIV ketamine - 10mg bolus may be repeated repeated 2-3 times depending on clinical judgement | Drug | Patients with significative post-operative pain despite |
Primary outcome
Reduction in pain score after ketamine use in PACU
Time frame: in the immediate post-operative period in recovery room
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is what is used most often in our recovery room for pain assessment. A score of 0/10 means no pain, and 10/10 means worst pain.
1 secondary outcome
Incidence of side effects after ketamine use
Time frame: in the immediate post-operative period in recovery room
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 19 Sep 2024.
- Background: PubMed 30570761Brinck EC, Tiippana E, Heesen M, Bell RF, Straube S, Moore RA, Kontinen V. Perioperative intravenous ketamine for acute postoperative pain in adults. Cochrane Database Syst Rev. 2018 Dec 20;12(12):CD012033. doi: 10.1002/14651858.CD012033.pub4.
- Background: PubMed 17444308Gillies A, Lindholm D, Angliss M, Orr A. The use of ketamine as rescue analgesia in the recovery room following morphine administration--a double-blind randomised controlled trial in postoperative patients. Anaesth Intensive Care. 2007 Apr;35(2):199-203.
- Background: PubMed 12598264Weinbroum AA. A single small dose of postoperative ketamine provides rapid and sustained improvement in morphine analgesia in the presence of morphine-resistant pain. Anesth Analg. 2003 Mar;96(3):789-795. doi: 10.1213/01.ANE.0000048088.17761.B4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Ketamine Adverse Reaction, run by University of Alberta 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 4 inclusion and 4 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 19 Sep 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Reduction in pain score after ketamine use in PACU (time frame: in the immediate post-operative period in recovery room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04701008, which also lists 3 linked publications.
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 19 Sep 2024.