UMIN-CTR Clinical Trial

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
Email	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
Email	nishim@dent.showa-u.ac.jp

Sponsor
Institute	Showa University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050378