Effect of Nefopam on Acute Postoperative Pain in Patients... | NCT01461031

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

NCT01461031

Sponsor

The Catholic University of Korea

Status

Completed

Last Update Posted

Feb 4, 2021Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Pain
Orthognathic Surgery

Interventions

nefopam
normal saline (control)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Oct 11, 2011

First Submission Date that Met QC Criteria

Oct 26, 2011

First Posted Date

Oct 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2021

Last Update Posted Date

Feb 4, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Young Eun Moon, Anesthesiology and Pain Medicine, Clinical Assitant Professor, The Catholic University of KoreaPrincipal Investigator

Lead Sponsor

The Catholic University of KoreaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nefopam	Drug	nefopam infusion for postoperative 24 hours
normal saline (control)	Drug	normal saline infusion for postoperative 24 hours

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain score on the visual analogue scale		after orthognathic surgery (up to postoperative 24 hours)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul St.Mary's Hospital		Seoul	Seocho-gu	137-701	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26725583	Derived	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.

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D009340	Nefopam
D000077330	Saline Solution

ID	Term
D010079	Oxazocines
D001392	Azocines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds