UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023015
Receipt number 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 18:07:05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Ito Hospital
Department of Surgery

Institute

Department

Personal name



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

Value
https://center6.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