UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028584 |
|---|---|
| Receipt number | 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 15:37:53 |
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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
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
fumio.bb@gmail.com
Sponsor or person
Institute
Aichi Childrens Health and Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032541
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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