NCT01461031

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 27, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

October 11, 2011

Last Update Submit

February 2, 2021

Conditions

PainOrthognathic Surgery

Keywords

painorthognathic

Outcome Measures

Primary Outcomes (1)

  • pain score on the visual analogue scale

    after orthognathic surgery (up to postoperative 24 hours)

Interventions

nefopamDRUG

nefopam infusion for postoperative 24 hours

normal saline (control)DRUG

normal saline infusion for postoperative 24 hours

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 20-60 years
  • undergoing elective orthognathic surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St.Mary's Hospital

Seoul, Seocho-gu, 137-701, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 26725583DERIVED

MeSH Terms

Conditions

Pain

Interventions

NefopamSaline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OxazocinesAzocinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Pain Medicine, Clinical Assitant Professor

Study Record Dates

First Submitted

October 11, 2011

First Posted

October 27, 2011

Study Start

October 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations

KR(1)