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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050378


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name