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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019912
Receipt No. R000008410
Scientific Title Postoperative Pain Management After General Anesthesia using Remifentanil
Date of disclosure of the study information 2015/11/24
Last modified on 2017/05/26

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Basic information
Public title Postoperative Pain Management After General Anesthesia using Remifentanil
Acronym Remifentanil and Pain Management
Scientific Title Postoperative Pain Management After General Anesthesia using Remifentanil
Scientific Title:Acronym Remifentanil and Pain Management
Region
Japan

Condition
Condition Minor oral and maxillofacial surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether postoperative pain score is affected with or without transition from remifentanil to morphine after oral and maxillofacial surgical procedures
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Post operative pain
Key secondary outcomes

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 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Morphine for postoperative pain
Interventions/Control_2 Placebo for postoperative pain
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Minor oral and maxillofacial surgical patients
Key exclusion criteria Patients with a history of adverse reactions to opiates, a history of postoperative nausea and vomiting, or chronic pain
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Satoki Inoue
Organization Nara Medical University
Division name Anesthesiology
Zip code
Address 840 Shijo-cho Kashihara Nara
TEL 0744-22-3051
Email seninoue@naramed-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Satoki Inoue
Organization Nara Medical University
Division name Anesthesiology
Zip code
Address 840 Shijo-cho Kashihara Nara
TEL 0744-22-3051
Homepage URL
Email seninoue@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Nara Medical University
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
Email

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
2015 Year 11 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 Completed
Date of protocol fixation
2010 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 24 Day
Last modified on
2017 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008410

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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