search
Back to results

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

Primary Purpose

Pain, Orthognathic Surgery

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
nefopam
normal saline (control)
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring pain, orthognathic

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • aged 20-60 years
  • undergoing elective orthognathic surgery

Exclusion Criteria:

  • pregnancy
  • psychiatric disease
  • hepatobiliary or renal disease
  • monoamine oxidase inhibitor-taking patients

Sites / Locations

  • Seoul St.Mary's Hospital

Outcomes

Primary Outcome Measures

pain score on the visual analogue scale

Secondary Outcome Measures

Full Information

First Posted
October 11, 2011
Last Updated
February 2, 2021
Sponsor
The Catholic University of Korea
search

1. Study Identification

Unique Protocol Identification Number
NCT01461031
Brief Title
Effect of Nefopam on Acute Postoperative Pain in Patients Undergoing Orthognathic Surgery
Official Title
Effect of Nefopam on Acute Postoperative Pain in Patients Undergoing Orthognathic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to determine the analgesic effect of perioperative nefopam on acute pain in patient undergoing orthognathic surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Orthognathic Surgery
Keywords
pain, orthognathic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
nefopam
Intervention Description
nefopam infusion for postoperative 24 hours
Intervention Type
Drug
Intervention Name(s)
normal saline (control)
Intervention Description
normal saline infusion for postoperative 24 hours
Primary Outcome Measure Information:
Title
pain score on the visual analogue scale
Time Frame
after orthognathic surgery (up to postoperative 24 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Seoul St.Mary's Hospital
City
Seoul
State/Province
Seocho-gu
ZIP/Postal Code
137-701
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26725583
Citation
Park HJ, Park JU, Yoo W, Moon YE. Analgesic effects of nefopam in patients undergoing bimaxillary osteotomy: A double-blind, randomized, placebo-controlled study. J Craniomaxillofac Surg. 2016 Feb;44(2):210-4. doi: 10.1016/j.jcms.2015.11.012. Epub 2015 Dec 1.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs