NCT04701008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
Last Updated

September 19, 2024

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

January 5, 2021

Last Update Submit

September 11, 2024

Conditions

Keywords

pain score reductionreduction in pain scorespost-operative painketamine use in recovery roomrecovery roomketamine recoveryketamine rescue

Outcome Measures

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.

    in the immediate post-operative period in recovery room

Secondary Outcomes (1)

  • Incidence of side effects after ketamine use

    in the immediate post-operative period in recovery room

Study Arms (1)

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

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

Patients with significative post-operative pain despite

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Patient refusal to receive ketamine
  • Patients undergoing cardiac surgery
  • Patients who received no narcotics
  • Contra-indication to receiving ketamine (determined by attending anesthesiologist)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, t6g2b7, Canada

Location

Related Publications (3)

  • 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.

    PMID: 30570761BACKGROUND
  • 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.

    PMID: 17444308BACKGROUND
  • 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.

    PMID: 12598264BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativePain, IntractableAcute Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 8, 2021

Study Start

September 1, 2020

Primary Completion

May 28, 2021

Study Completion

May 28, 2021

Last Updated

September 19, 2024

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations