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Efficacy of Ketamine in Post Anesthesia Recovery Room

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ClinicalTrials.gov Identifier: NCT04701008
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Derek Dillane, University of Alberta

Tracking Information
First Submitted Date January 5, 2021
First Posted Date January 8, 2021
Last Update Posted Date January 15, 2021
Actual Study Start Date September 15, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 13, 2021)
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.
Original Primary Outcome Measures
 (submitted: January 5, 2021)
Reduction in pain score after ketamine use in PACU [ Time Frame: in the immediate post-operative period in recovery room ]
Change History
Current Secondary Outcome Measures
 (submitted: January 5, 2021)
Incidence of side effects after ketamine use [ Time Frame: in the immediate post-operative period in recovery room ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Efficacy of Ketamine in Post Anesthesia Recovery Room
Official Title Observational Study of the Efficacy of Ketamine for Rescue Analgesia in the Post Anesthesia Recovery Room
Brief 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.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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
Condition
  • Pain, Postoperative
  • Ketamine Adverse Reaction
  • Pain, Refractory
  • Pain, Intractable
  • Pain, Acute
Intervention Drug: Ketamine
IV ketamine - 10mg bolus may be repeated repeated 2-3 times depending on clinical judgement
Study Groups/Cohorts 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.
Intervention: Drug: Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 5, 2021)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Derek Dillane (780) 407-8861 dillane@ualberta.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04701008
Other Study ID Numbers Pro00102967
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Derek Dillane, University of Alberta
Study Sponsor University of Alberta
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Alberta
Verification Date January 2021