An observational study in Pain, Postoperative, Ketamine Adverse Reaction and Pain, Refractory, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Alberta · Observational
Observational study to assess efficacy of IV ketamine bolus when used in the post anesthesia recovery unit for uncontrolled pain despite use of opioids.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 143 is above the median of 102 across 683 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adult patients undergoing non cardiac surgery at University of Alberta Hospital meeting the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Ketamine
IV ketamine - 10mg bolus may be repeated repeated 2-3 times depending on clinical judgement
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.
Time frame: in the immediate post-operative period in recovery room
Incidence of side effects after ketamine use
Time frame: in the immediate post-operative period in recovery room
Plan to share: No
Ran from Sep 2020 to primary completion in May 2021, 8 months.
Of 391 non-industry observational studies under Pain, Postoperative, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's 8 months is below that.
Counting every sponsor, half of 395 studies reached it within 13 months; a quarter within 5 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. 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.