UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028339 |
|---|---|
| Receipt number | 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 14:02:36 |
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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
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
mmctm2@yahoo.co.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032437
