UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of injection pain in pediatric population; original versus generic rocuronium
Title of the study (Brief title)	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	Fumio Watanabe
Organization	Aichi Childrens Health and Medical Center
Division name	Department of anesthesiology
Address	7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL	0562-43-0500
Email	fumio.bb@gmail.com

Public contact
Name of contact person	Fumio Watanabe
Organization	Aichi Childrens Health and Medical Center
Division name	Department of anesthesiology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 07 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	No difference of injection pain between original versus generic rocuronium
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/icdr_e/ctr_view.cgi?recptno=R000032541