UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019431 |
|---|---|
| Receipt number | R000022458 |
| Scientific Title | Comparison of various oral analgesic effects for post-operative pain following minor oral surgery |
| Date of disclosure of the study information | 2015/10/21 |
| Last modified on | 2016/02/01 10:05:16 |
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Basic information
Public title
Comparison of various oral analgesic effects for post-operative pain following minor oral surgery
Acronym
Comparison of various oral analgesic effects for post-operative pain following minor oral surgery
Scientific Title
Comparison of various oral analgesic effects for post-operative pain following minor oral surgery
Scientific Title:Acronym
Comparison of various oral analgesic effects for post-operative pain following minor oral surgery
Region
| Japan |
Condition
Condition
Impacted wisdom tooth
Jaw deformities
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Non-steroidal anti-inflammatory drugs (NSAIDs) has been frequently used for post-operative pain following minor oral surgery. However, side effects such as gastrointestinal disorders and platelet function suppression have been a problem. The purpose of this study is to investigate whether celecoxib as a COX-2 selective inhibitors and acetaminophen with less side effects are similar with diclofenac sodium as conventional NSAIDs or not.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative fentanyl consumption at 5 hours after study drug administration.
Postoperative VAS at 5 hours after study drug administration.
Key secondary outcomes
Duration of the first use of IV-PCA following study drug administration.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of 1000 mg Acetaminophen at 15 minutes before the start of surgery.
IV-PCA was used during postoperative 6 hours.
A bolus of fentanyl on demand and a lockout time were set at 0.02mg and 10min, respectively.
Interventions/Control_2
Administration of 400 mg Celecoxib at 15 minutes before the start of surgery.
IV-PCA was used during postoperative 6 hours.
A bolus of fentanyl on demand and a lockout time were set at 0.02mg and 10min, respectively.
Interventions/Control_3
Administration of 50 mg Diclofenac sodium at 15 minutes before the start of surgery.
IV-PCA was used during postoperative 6 hours.
A bolus of fentanyl on demand and a lockout time were set at 0.02mg and 10min, respectively.
Interventions/Control_4
Administration of Placebo at 15 minutes before the start of surgery.
IV-PCA was used during postoperative 6 hours.
A bolus of fentanyl on demand and a lockout time were set at 0.02mg and 10min, respectively.
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
Healthy adults of ASA classification 1-2 degrees from 20 years old to 65 years old
Key exclusion criteria
Post history of upper gastrointestinal tract disorder.
NSAIDs addict.
ASA classification of 3 or more.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | hanzawa atsushi |
Organization
Tokyo Dental College
Division name
Department of Oral Health and Clinical Science, Division of Special Needs De ntistry and Orofacial Pain
Zip code
Address
2-9-18, Misakicho Chiyoda-ku, Tokyo
TEL
0352751851
hanzawaatsushi@tdc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | hanzawa atsushi |
Organization
Tokyo Dental College
Division name
Department of Oral Health and Clinical Science, Division of Special Needs De ntistry and Orofacial P
Zip code
Address
2-9-18, Misakicho Chiyoda-ku, Tokyo
TEL
0352751851
Homepage URL
hanzawaatsushi@tdc.ac.jp
Sponsor or person
Institute
Department of Oral Health and Clinical Science, Division of Special Needs De
ntistry and Orofacial Pain, Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Department of Oral Health and Clinical Science, Division of Special Needs De
ntistry and Orofacial Pain, Tokyo Dental College
Organization
Division
Category of Funding Organization
Other
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
東京歯科大学水道橋病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 05 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 21 | Day |
Last modified on
| 2016 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022458
