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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04701008
Other study ID # Pro00102967
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date May 28, 2021

Study information

Verified date July 2022
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 143
Est. completion date May 28, 2021
Est. primary completion date May 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Canada University of Alberta Hospital Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & 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:CD012033. doi: 10.1002/14651858.CD012033.pub4. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Incidence of side effects after ketamine use in the immediate post-operative period in recovery room
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