UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002540 |
|---|---|
| Receipt number | R000003106 |
| Scientific Title | Effects of fentanyl added to mepivacaine for inferior alveolar nerve block duration, double blind, randomized trial |
| Date of disclosure of the study information | 2009/09/24 |
| Last modified on | 2014/03/24 09:06:42 |
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Basic information
Public title
Effects of fentanyl added to mepivacaine for inferior alveolar nerve block duration, double blind, randomized trial
Acronym
Effects of fentanyl added to mepivacaine for inferior alveolar nerve block duration
Scientific Title
Effects of fentanyl added to mepivacaine for inferior alveolar nerve block duration, double blind, randomized trial
Scientific Title:Acronym
Effects of fentanyl added to mepivacaine for inferior alveolar nerve block duration
Region
| Japan |
Condition
Condition
Missing tooth of mandibular
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Opioids added local anesthetic solution prolongs analgesia in axillary brachial plexus block,however there were no report about local anesthesia with opioid in maxillo facial arear. When dental injection,sometime ingrease blood pressure and heart rate caused vasoconstrictor. Therefore some dentist prefer plane anesthetic solutions. But they can't use every procedure because no vasoconstrictor solution do not have enough effect time. We will examine the efficacy and safety of IANB for fentanyl added to mepivacaine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Time from injection to disappear anesthetic effect
Incidence of PONV until next day
Key secondary outcomes
Successful rate
1=no paine at recovery
2=paine at recovery
3=need extra injection during procedure
4=need extra injection when procedure start
Successful rate=1+2+3/1+2+3+4
Dose of NSAIDs
Dose of NSAIDs until next day
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
GroupM
3% Mepivacaine 3.0ml with saline 0.5ml for IANB and 0.5ml saline iv.
1.Eight hour diet beforeprocedure.
2.Take venous line put on regular monitor and BIS
3.Give Oxygen and Nitrous Oxide via nasal canula.
4.Start propofol sedation and IANB
5.Infiltration anesthesia to buccal side by lidocaine with adrenaline
6.If patient have pain,he/she can take roxoprofen Na
Study start 09/10/2009
Study finish 12/31/2010
Interventions/Control_2
GroupFM 3%Mepivacaine3.0mlwith fentanyl 0.5ml for IANB and 0.5ml saline iv
Method is same as group M
Interventions/Control_3
GroupIFM 3%Mepivacaine3.0ml with saline 0.5ml for IANB and 0.5ml fentanyl iv
Method is same as group M
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
There are taken informed concent among dental implant patient under iv sedation at Nippon Dental University hospital.
Key exclusion criteria
Bone graft case
Body weight under 40kg
Age under20
Have heart disease overNYHA2
Have lever or kidney disorder
Take tranquilizers regularly
Have drug,bean,egg,allergy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | katsuhisa sunada |
Organization
The Nippon Dental University
Division name
dental anesthesiology
Zip code
Address
1-9-20 fujimi chiyoda Tokyo
TEL
03(3261)8311
katsu.sunada@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | katsuhisa sunada |
Organization
The Nippon Dental University
Division name
dental anesthesiology
Zip code
Address
1-9-20 fujimi chiyodaku Tokyo
TEL
03(3261)8311
Homepage URL
katsu.sunada@nifty.com
Sponsor or person
Institute
The Nippon Dental University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
日本歯科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Terminated
Date of protocol fixation
| 2009 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 24 | Day |
Last modified on
| 2014 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003106
