UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010484 |
|---|---|
| Receipt number | R000012257 |
| Scientific Title | Slow injection of nefopam reduces pain intensity associated with intravenous injection: A clinical trial |
| Date of disclosure of the study information | 2013/04/13 |
| Last modified on | 2014/08/22 14:17:17 |
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Basic information
Public title
Slow injection of nefopam reduces pain intensity associated with intravenous injection: A clinical trial
Acronym
Slow injection of nefopam reduces injection pain
Scientific Title
Slow injection of nefopam reduces pain intensity associated with intravenous injection: A clinical trial
Scientific Title:Acronym
Slow injection of nefopam reduces injection pain
Region
| Asia(except Japan) |
Condition
Condition
elective minor surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate how frequently and severely the i.v. administration of nefopam can cause pain, and determine whether control of administration rate of nefopam can effectively reduce the injection pain in terms of incidence and intensity.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual analogue pain scale at intravenous injection of nefopam
Key secondary outcomes
Adverse effects including phlebitis caused by nefopam injection
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The i.v. solution (30 mg of nefopam is diluted with 0.9% isotonic saline to a total volume of 20 mL) is administered at a rate of 60 mL/h
Interventions/Control_2
The i.v. solution (30 mg of nefopam is diluted with 0.9% isotonic saline to a total volume of 20 mL) is administered at a rate of 120 mL/h
Interventions/Control_3
The i.v. solution (30 mg of nefopam is diluted with 0.9% isotonic saline to a total volume of 20 mL) is administered at a rate of 180 mL/h
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 20~65 years with a physical status of 1 (the American Society of Anesthesiologists rating) who are scheduled to undergo elective minor surgery
Key exclusion criteria
Patients with a history of cardiovascular, kidney, or liver disease, those with a current convulsive disorder or hypersensitivity to drugs, and those receiving any analgesics; Patients with a vein that do not drain well; those with redness, swelling, and tenderness along the veins; and those with a history of difficult peripheral venous cannulation.
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Byung Gun Lim |
Organization
Guro Hospital, Korea University College of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
Address
148 Gurodong-ro, Guro-gu, Seoul, Korea
TEL
82-2-2626-1437
bglim9205@korea.ac.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Byung Gun Lim |
Organization
Guro Hospital, Korea University College of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
Address
148 Gurodong-ro, Guro-gu, Seoul, Korea
TEL
82-2-2626-1437
Homepage URL
bglim9205@korea.ac.kr
Sponsor or person
Institute
Korea University
Institute
Department
Personal name
Funding Source
Organization
Korea University
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Korea University Guro Hospital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Slow injection of nefopam reduces pain intensity associated with intravenous injection: a prospective randomized trial.
Kim YM, Lim BG, Kim H, Kong MH, Lee MK, Lee IO.
J Anesth. 2014 Jun;28(3):399-406. doi: 10.1007/s00540-013-1744-z. Epub 2013 Nov 8.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
| 2013 | Year | 04 | Month | 24 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 25 | Day |
Date analysis concluded
| 2013 | Year | 04 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 13 | Day |
Last modified on
| 2014 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012257
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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