- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04701008
Efficacy of Ketamine in Post Anesthesia Recovery Room
Observational Study of the Efficacy of Ketamine for Rescue Analgesia in the Post Anesthesia Recovery Room
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Alberta
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Edmonton, Alberta, Canada, t6g2b7
- University of Alberta Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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:
- age ≥ 18
- significant pain despite narcotics used in post anesthesia care unit
- ketamine ordered by attending anesthesiologist
Description
Inclusion Criteria:
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
Exclusion Criteria:
- Patient refusal to receive ketamine
- Patients undergoing cardiac surgery
- Patients who received no narcotics
- Contra-indication to receiving ketamine (determined by attending anesthesiologist)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
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IV ketamine - 10mg bolus may be repeated repeated 2-3 times depending on clinical judgement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
in the immediate post-operative period in recovery room
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of side effects after ketamine use
Time Frame: in the immediate post-operative period in recovery room
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in the immediate post-operative period in recovery room
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Gillies 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.
- Weinbroum 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Pain, Intractable
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- Pro00102967
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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