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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023015
Receipt No. R000026525
Scientific Title Usefulness of paracetamol for acute pain after thyroid surgery
Date of disclosure of the study information 2016/07/04
Last modified on 2016/07/04

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Basic information
Public title Usefulness of paracetamol for acute pain after thyroid surgery
Acronym Usefulness of paracetamol for acute pain after thyroid surgery
Scientific Title Usefulness of paracetamol for acute pain after thyroid surgery
Scientific Title:Acronym Usefulness of paracetamol for acute pain after thyroid surgery
Region
Japan

Condition
Condition Thyroid and parathyroid disease
Classification by specialty
Endocrine surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of paracetamol for acute pain after thyroid surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effectiveness for acute pain
Key secondary outcomes Time to first ambulation from bed rest after surgery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 pantazocine (15mg)(Group P)
Interventions/Control_2 pentazocine(15mg)+hydroxyzine (25mg)(Group PH)
Interventions/Control_3 paracetamol (500-1000mg)(Group A)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All the patients who consented to participate in this randomized control trial were enrolled.
Key exclusion criteria The patients who had known allergy to pentazocine, hydroxyzine and acetaminophen.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Uruno
Organization Ito Hospital
Division name Surgery
Zip code
Address 4-3-6 Jingumae, Shibuya-ku, Tokyo, Japan
TEL 03-3402-7411
Email t-uruno@ito-hospital.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Uruno
Organization Ito Hospital
Division name Surgery
Zip code
Address 4-3-6 Jingumae, Shibuya-ku, Tokyo, Japan
TEL 03-3402-7411
Homepage URL
Email t-uruno@ito-hospital.jp

Sponsor
Institute Ito Hospital
Department of Surgery
Institute
Department

Funding Source
Organization Ito Hospital
Department of Surgery
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
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 伊藤病院

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 04 Day

Related information
URL releasing protocol
Publication of results 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 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 17 Day
Last follow-up date
2015 Year 06 Month 26 Day
Date of closure to data entry
2015 Year 06 Month 27 Day
Date trial data considered complete
2015 Year 06 Month 27 Day
Date analysis concluded
2015 Year 07 Month 05 Day

Other
Other related information

Management information
Registered date
2016 Year 07 Month 04 Day
Last modified on
2016 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026525

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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