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

• Sponsor: The Catholic University of Korea (Other)
• Overall Status: Completed
• CT.gov ID: NCT01461031
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 11
• Patients Per Site Per Month: 3.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Orthognathic Surgery	Drug: nefopam; Drug: normal saline (control)	N/A

Study Design

• Study Type: Interventional
• Actual 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: Oct 1, 2011
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Outcome Measures

Primary Outcome Measures

1. pain score on the visual analogue scale [after orthognathic surgery (up to postoperative 24 hours)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Seoul St.Mary's Hospital	Seoul	Seocho-gu	Korea, Republic of	137-701

Sponsors and Collaborators

• The Catholic University of Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Oct 27, 2011
• Last Update Posted: Feb 4, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Young Eun Moon, Anesthesiology and Pain Medicine, Clinical Assitant Professor, The Catholic University of Korea: pain; orthognathic
• Additional relevant MeSH terms: Pain, Postoperative; Nefopam

Study Results

No Results Posted as of Feb 4, 2021