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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028339
Receipt No. R000032437
Scientific Title Intravenous acetaminophen for analgesia after skin laser irradiation surgery in pediatrics: a retrospective and double-blinded prospective randomized placebo-controlled single-center study
Date of disclosure of the study information 2017/07/24
Last modified on 2017/07/23

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Basic information
Public title Intravenous acetaminophen for analgesia after skin laser irradiation surgery in pediatrics: a retrospective and double-blinded prospective randomized placebo-controlled single-center study
Acronym Intravenous acetaminophen for analgesia after skin laser irradiation surgery in pediatrics
Scientific Title Intravenous acetaminophen for analgesia after skin laser irradiation surgery in pediatrics: a retrospective and double-blinded prospective randomized placebo-controlled single-center study
Scientific Title:Acronym Intravenous acetaminophen for analgesia after skin laser irradiation surgery in pediatrics
Region
Japan

Condition
Condition nevus
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Acetaminophen is an effective analgetic drug for postoperative pain relief and able to be used for children. In Japan, intravenous acetaminophen could be clinically used since 2013. Skin laser irradiation surgery for pediatric nevus is performed under general anesthesia, and many drugs have been used for postoperative pain relief during surgery. We aimed to demonstrate the availability of intravenous acetaminophen in a prospective, randomized controlled trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Behavioral Observational Pain Scale (BOPS) and subjective face scale (sFS)
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 control: placebo (normal saline)
Interventions/Control_2 intervention: intravenous acetaminophen
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
1 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria ASAI or II.
Patients were obtained IC.
Key exclusion criteria 0 years old and over 13 years old.
Allergy for acetaminophen.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Kuroki
Organization University of Miyazaki Hospital
Division name Departments of Anesthesiology
Zip code
Address Department of Anesthesiology, University of Miyazaki Hospital, Miyazaki 889-1692, Japan.
TEL 0985-85-2970
Email mmctm2@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toyoaki Maruta
Organization University of Miyazaki Hospital
Division name Departments of Anesthesiology
Zip code
Address Department of Anesthesiology, University of Miyazaki Hospital, Miyazaki 889-1692, Japan.
TEL 0985-85-2970
Homepage URL
Email mmctm2@yahoo.co.jp

Sponsor
Institute University of Miyazaki
Institute
Department

Funding Source
Organization University of Miyazaki
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 YES
Study ID_1 2014-012
Org. issuing International ID_1 the hospital ethics committee for human studies
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 宮崎大学病院 (宮崎県)

Other administrative information
Date of disclosure of the study information
2017 Year 07 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
2014 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 07 Day
Last follow-up date
Date of closure to data entry
2016 Year 04 Month 16 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 23 Day
Last modified on
2017 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032437

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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