|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000031692 |
|
Date of registration:
|
12/03/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty
|
|
Scientific title:
|
Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty - Efficacy of intravenous acetaminophen injection for pain management after TKA |
|
Date of first enrolment:
|
2018/03/01 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035418 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel Randomized
|
|
Phase:
|
Not selected
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Kazushige
Seki |
|
Address:
|
1-1-1 Minamikogushi, Ube, Yamaguchi 755-0046, Japan
Japan |
|
Telephone:
|
0836-22-2268 |
|
Email:
|
sk0105@yamaguchi-u.ac.jp |
|
Affiliation:
|
Yamaguchi University Graduate School of Medicine Department of Orthopedic Surgery |
|
|
Name:
|
Kazushige
Seki |
|
Address:
|
1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan
7558505
Japan |
|
Telephone:
|
0836-22-2268 |
|
Email:
|
sk0105@yamaguchi-u.ac.jp |
|
Affiliation:
|
Yamaguchi University Graduate School of Medicine Department of Orthopedic Surgery |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: 1)Aspirin-induced asthma or a history of diseases of aspirin-induced asthma. 2)Any subject with a past history of anaphylaxis due to acetaminophen. Any subject with blood abnormality, hepatopathy, kidney damage or cardiac dysfunction. 3)patients with liver failure. 4)Patients with NSAIDS contraindications 5)Women who are pregnant, maybe pregnant or lactation. 6)Any subject with blood abnormality, hepatopathy, kidney damage or cardiac dysfunction. 7)Any condition that, in the opinion of the investigator, would make the patient unsuitable for inclusion in the study.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
knee osteoarthritis rheumatoid arthritis
|
|
Intervention(s)
|
Study group:Fentanyl sustained intravenous administration given after operation end. And use the Intravenous acetaminophen 4 times per 6 hour.Dosage is 15 mg/kg for the patient less than 50 kg in weight and 1000 mg for the patient more than 50 kg in weight.
Control group:Fentanyl sustained intravenous administration given after operation end.
|
|
Primary Outcome(s)
|
|
Pain intensity at rest is measured with NRS for 24 hours after surgery.
|
|
Source(s) of Monetary Support
|
|
Department of orthropedic surgery, Yamaguchi University Graduate School of Medicine
|
|
Ethics review
|
Status: YES
Approval date: 27/12/2017
Contact:
me223@yamaguchi-u.ac.jp
Center For Clinical Research, Yamaguchi University Hospital
0836-22-2428
me223@yamaguchi-u.ac.jp
|
|