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CompletedNCT04701008Updated Sep 19, 2024

Efficacy of Ketamine in Post Anesthesia Recovery Room

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
143
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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

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

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)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
143 participants (actual)
Patient registry
No

Groups and 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.

    Drug: Ketamine

Interventions

  • DrugKetamine

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

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of side effects after ketamine use

    Time frame: in the immediate post-operative period in recovery room

06

Study locations

1 site
  • University of Alberta Hospital
    Edmonton, Alberta t6g2b7, Canada
07

References and documents

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 30570761 ↗
  • 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. PubMed 17444308 ↗
  • 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. PubMed 12598264 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04701008
Lead sponsor
University of Alberta
Responsible party
Sponsor
First posted
Jan 8, 2021
Start date
Sep 1, 2020
Primary completion
May 28, 2021
Completion
May 28, 2021
Last update
Sep 19, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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