Efficacy of Ketamine in Post Anesthesia Recovery Room

Sponsor
University of Alberta (Other)
Overall Status
Completed
CT.gov ID
NCT04701008
Collaborator
(none)
143
1
8.8
16.2

Study Details

Study Description

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 Design

Study Type:
Observational
Actual Enrollment :
143 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Study of the Efficacy of Ketamine for Rescue Analgesia in the Post Anesthesia Recovery Room
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
May 28, 2021
Actual Study Completion Date :
May 28, 2021

Arms and Interventions

Arm 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.

Drug: Ketamine
IV ketamine - 10mg bolus may be repeated repeated 2-3 times depending on clinical judgement

Outcome Measures

Primary Outcome Measures

  1. Reduction in pain score after ketamine use in PACU [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.

Secondary Outcome Measures

  1. Incidence of side effects after ketamine use [in the immediate post-operative period in recovery room]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alberta Hospital Edmonton Alberta Canada t6g2b7

Sponsors and Collaborators

  • University of Alberta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Alberta
ClinicalTrials.gov Identifier:
NCT04701008
Other Study ID Numbers:
  • Pro00102967
First Posted:
Jan 8, 2021
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by University of Alberta
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022