PainNCT01461031
Effect of Nefopam on Acute Postoperative Pain in Patients Undergoing Orthognathic Surgery
A study testing nefopam in people with Pain and Orthognathic Surgery, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
The aim of this study is to determine the analgesic effect of perioperative nefopam on acute pain in patient undergoing orthognathic surgery. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Orthognathic Surgery
- What is being tested?
- nefopam
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 20-60 years
- undergoing elective orthognathic surgery
Who cannot join
- pregnancy
- psychiatric disease
- hepatobiliary or renal disease
- monoamine oxidase inhibitor-taking patients
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine the analgesic effect of perioperative nefopam on acute pain in patient undergoing orthognathic surgery.
- Conditions
- Pain, Orthognathic Surgery
- Being tested
- nefopam, normal saline (control)
- Keywords
- pain, orthognathic
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nefopamDrug
nefopam infusion for postoperative 24 hours
normal saline (control)Drug
normal saline infusion for postoperative 24 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score on the visual analogue scale
Measured: after orthognathic surgery (up to postoperative 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Eun Moon, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461031
- Sponsor's protocol ID
- nefopam-orthognathic
- Status last verified
- Feb 2021
- First submitted
- 11 Oct 2011
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26725583
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nefopam on Acute Postoperative Pain in Patients Undergoing Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT01461031
- Acronym / sponsor ID
- nefopam-orthognathic
- Conditions
- Pain, Orthognathic Surgery
- Keywords
- pain, orthognathic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 27 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the analgesic effect of perioperative nefopam on acute pain in patient undergoing orthognathic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- aged 20-60 years
- undergoing elective orthognathic surgery
Key exclusion criteria (4 listed)
- pregnancy
- psychiatric disease
- hepatobiliary or renal disease
- monoamine oxidase inhibitor-taking patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nefopamnefopam infusion for postoperative 24 hours | Drug | – |
| normal saline (control)normal saline infusion for postoperative 24 hours | Drug | – |
Primary outcome
pain score on the visual analogue scale
Time frame: after orthognathic surgery (up to postoperative 24 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 26725583Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nefopam in people with Pain and Orthognathic Surgery, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score on the visual analogue scale (time frame: after orthognathic surgery (up to postoperative 24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01461031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.