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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028584
Receipt No. R000032541
Scientific Title Comparison of injection pain in pediatric population; original versus generic rocuronium
Date of disclosure of the study information 2017/08/20
Last modified on 2018/08/13

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Basic information
Public title Comparison of injection pain in pediatric population; original versus generic rocuronium
Acronym Comparison of injection pain in pediatric population; original versus generic rocuronium
Scientific Title Comparison of injection pain in pediatric population; original versus generic rocuronium
Scientific Title:Acronym Comparison of injection pain in pediatric population; original versus generic rocuronium
Region
Japan

Condition
Condition Patients ranging in age from 1 to 15 years, American Society of Anaesthesiologists (ASA) physical status 1or 2, and undergoing following elective surgeries; laparoscopic percutaneous extraperitoneal closure (LPEC), vesicoureteral reflux operation, and orthopedic surgery for extremities.
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Rocuronium, one of the muscle relaxants, is known to cause injection pain occasionally with flexion of upper extremities. The incidence of rocuronium injection pain has been reported to be higher in pediatrics than adults. Generic rocuronium which recently came onto Japanese market has glycine as one of the buffer materials, and a study performed in rats suggested the injection pain by generic rocuronium was smaller than that of original rocuronium. Our objective is to compare injection pains caused by original and generic rocuronium in pediatric patients.
Basic objectives2 Others
Basic objectives -Others To verify the degree of side reaction
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcomes include the movement of the extremities after injecting rocuronium and the changes of vital signs (heart rate and blood pressure).
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We inject original rocuronium 1mg/kg into a vein during the induction of anesthesia.
Interventions/Control_2 We inject generic rocuronium 1mg/kg into a vein during the induction of anesthesia.
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
15 years-old >=
Gender Male and Female
Key inclusion criteria Patients ranging in age from 1 to 15 years, American Society of Anaesthesiologists (ASA) physical status 1or 2, and undergoing following elective surgeries; laparoscopic percutaneous extraperitoneal closure (LPEC), vesicoureteral reflux operation, and orthopedic surgery for extremities.
Key exclusion criteria Patients with allergy to any of the anesthetic medications being administered, neuromascular disease, or weak, thin dorsal veins were excluded from the study.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumio Watanabe
Organization Aichi Childrens Health and Medical Center
Division name Department of anesthesiology
Zip code
Address 7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL 0562-43-0500
Email fumio.bb@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Fumio Watanabe
Organization Aichi Childrens Health and Medical Center
Division name Department of anesthesiology
Zip code
Address 7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL 0562-43-0500
Homepage URL
Email fumio.bb@gmail.com

Sponsor
Institute Aichi Childrens Health and Medical Center
Institute
Department

Funding Source
Organization Aichi Childrens Health and Medical Center
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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 20 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
No difference of injection pain between original versus generic rocuronium
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 Main results already published
Date of protocol fixation
2017 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 20 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 05 Month 01 Day
Date trial data considered complete
2018 Year 05 Month 01 Day
Date analysis concluded
2018 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 08 Day
Last modified on
2018 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032541

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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