UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045554 |
|---|---|
| Receipt number | R000050378 |
| Scientific Title | The effects of intervention in intraoperative pain management on postoperative pain relief in wisdom teeth extraction under general anesthesia. |
| Date of disclosure of the study information | 2021/09/24 |
| Last modified on | 2022/03/25 22:36:42 |
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Basic information
Public title
The relationship between intervention in administration time of intraoperative analgesics and postoperative pain in wisdom teeth extraction under general anesthesia.
Acronym
The relationship between intervention in intraoperative analgesics and postoperative pain in wisdom teeth extraction under general anesthesia.
Scientific Title
The effects of intervention in intraoperative pain management on postoperative pain relief in wisdom teeth extraction under general anesthesia.
Scientific Title:Acronym
The effects of intraoperative intervention
on postoperative pain in minor surgery under general anesthesia.
Region
| Japan |
Condition
Condition
pericoronitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of analgesic effect in acetaminophen intravenous injection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree and presence of postoperative pain.
Key secondary outcomes
consciousness level, vital signs, adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group administered immediately before the end of surgery.
Interventions/Control_2
Group administered 2 hours before the estimated end of the general anesthesia
Interventions/Control_3
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients with ASA PS1-2 who are scheduled to undergo bilateral mandibular tooth extraction under general anesthesia in Showa University Dental Hospital and will be hospitalized for three days.
2)Adult patients whose age at the time of consent is 20 to 60 years old.
3)Patients with mandibular impacted wisdom teeth mesial tilted who require bone removal and crown division during tooth extraction.
4)Patients who do not need bone removal for maxillary extraction when including maxillary wisdom teeth.
5)Patients who have given written consent to participate in this study.
Key exclusion criteria
1)Patients with contraindications to acetaminophen
Patients with aspirin asthma.
Patients with severe liver disorder, renal disorder cardiac dysfunction, blood abnormality.
Patients with peptic ulcer.
Patients with a history of hypersensitivity to acetaminophen.
2)Patients using supplementary analgesics.
3)atients who are contraindicated for the administration of dental 2% lidocaine.
Patients with hypertension, arteriosclerosis, heart failure, hyperthyroidism, diabetes mellitus and history of vascular spasm.
4)Patients with a history of hypersensitivity to general anesthetic.
5)Patients with painful oral complications that may affect the efficacy evaluation.
6)Patients scheduled for surgery other than tooth extraction.
7)Patients who cannot communicate and cannot express pain. Patients who have difficulty operating peripheral nerve stimulators.
8)Patients who had other wisdom teeth extracted before 45 days.
9)Patients who have used other non-steroidal anti-inflammatory drugs or antipyretic analgesics including topical drugs before 2 days.
10)Patients with BMI 30 or above.
11)Patients who are pregnant or breast-feeding.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Nishimura |
Organization
Showa university dental hospital
Division name
Dental anesthesiology
Zip code
145-8515
Address
2-1-1 Kitasenzoku, Ota-ku, Tokyo
TEL
03-3787-1151
nishim@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Nishimura |
Organization
Showa university dental university
Division name
Dental anesthesiology
Zip code
145-8515
Address
2-1-1 Kitasenzoku, Ota-ku, Tokyo
TEL
0337871151
Homepage URL
nishim@dent.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa university
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
Showa university dental hospital institutional review board
Address
2-1-1, kitasenzoku, Ota-ku, Tokyo
Tel
03-3787-1151
dh-ctrial@ofc.showa-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2021 | 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
26
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
| 2021 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 24 | Day |
Last modified on
| 2022 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050378
