- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01461031
Effect of Nefopam on Acute Postoperative Pain in Patients Undergoing Orthognathic Surgery
February 2, 2021 updated by: Young Eun Moon, The Catholic University of Korea
The aim of this study is to determine the analgesic effect of perioperative nefopam on acute pain in patient undergoing orthognathic surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Seocho-gu
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Seoul, Seocho-gu, Korea, Republic of, 137-701
- Seoul St.Mary's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 20-60 years
- undergoing elective orthognathic surgery
Exclusion Criteria:
- pregnancy
- psychiatric disease
- hepatobiliary or renal disease
- monoamine oxidase inhibitor-taking patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: QUADRUPLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pain score on the visual analogue scale
Time Frame: after orthognathic surgery (up to postoperative 24 hours)
|
after orthognathic surgery (up to postoperative 24 hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (ACTUAL)
September 1, 2012
Study Completion (ACTUAL)
September 1, 2012
Study Registration Dates
First Submitted
October 11, 2011
First Submitted That Met QC Criteria
October 26, 2011
First Posted (ESTIMATE)
October 27, 2011
Study Record Updates
Last Update Posted (ACTUAL)
February 4, 2021
Last Update Submitted That Met QC Criteria
February 2, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- nefopam-orthognathic
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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