UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intravenous acetaminophen for analgesia after skin laser irradiation surgery in pediatrics: a retrospective and double-blinded prospective randomized placebo-controlled single-center study
Title of the study (Brief title)	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	Shunsuke Kuroki
Organization	University of Miyazaki Hospital
Division name	Departments of Anesthesiology
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	Toyoaki Maruta
Organization	University of Miyazaki Hospital
Division name	Departments of Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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