Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Nefopam on Acute Postoperative Pain in Patients Undergoing Orthognathic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01461031
Recruitment Status : Unknown
Verified July 2012 by Young Eun Moon, The Catholic University of Korea.
Recruitment status was:  Recruiting
First Posted : October 27, 2011
Last Update Posted : July 6, 2012
Sponsor:
Information provided by (Responsible Party):
Young Eun Moon, The Catholic University of Korea

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of this study is to determine the analgesic effect of perioperative nefopam on acute pain in patient undergoing orthognathic surgery.

Condition or disease Intervention/treatment Phase
Pain Orthognathic Surgery Drug: nefopam Drug: normal saline (control) Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Nefopam on Acute Postoperative Pain in Patients Undergoing Orthognathic Surgery
Study Start Date : October 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Drug: nefopam
    nefopam infusion for postoperative 24 hours
  • Drug: normal saline (control)
    normal saline infusion for postoperative 24 hours

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. pain score on the visual analogue scale [ Time Frame: after orthognathic surgery (up to postoperative 24 hours) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged 20-60 years
  • undergoing elective orthognathic surgery

Exclusion Criteria:

  • pregnancy
  • psychiatric disease
  • hepatobiliary or renal disease
  • monoamine oxidase inhibitor-taking patients
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461031


Contacts
Layout table for location contacts
Contact: Young Eun Moon, M.D. 822-2258-6163 momo0910@hanmail.net

Locations
Layout table for location information
Korea, Republic of
Seoul St.Mary's Hospital Recruiting
Seoul, Seocho-gu, Korea, Republic of, 137-701
Sponsors and Collaborators
The Catholic University of Korea
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Young Eun Moon, Anesthesiology and Pain Medicine, Clinical Assitant Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01461031    
Other Study ID Numbers: nefopam-orthognathic
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: July 2012
Keywords provided by Young Eun Moon, The Catholic University of Korea:
pain
orthognathic
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Nefopam
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs