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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010469
Receipt No. R000012234
Scientific Title The effect of intravenous infusion of ketamine on postoperative pain after idiopathic scoliosis surgery
Date of disclosure of the study information 2013/04/16
Last modified on 2015/03/02

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Basic information
Public title The effect of intravenous infusion of ketamine on postoperative pain after idiopathic scoliosis surgery
Acronym The effect of intravenous infusion of ketamine on postoperative pain after idiopathic scoliosis surgery
Scientific Title The effect of intravenous infusion of ketamine on postoperative pain after idiopathic scoliosis surgery
Scientific Title:Acronym The effect of intravenous infusion of ketamine on postoperative pain after idiopathic scoliosis surgery
Region
Japan

Condition
Condition Idiopathic scoliosis, scheduled to undergo psterior instrumentation
Classification by specialty
Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether intra- and post-operaive infusion of ketamine would decrease postoperative morphine consumption and level of postoperative pain after idiopathic scoliosis surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Postoperative morphine consumption
Key secondary outcomes Verbal Rating Scale, Numerical Rating Scale

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intervention:Ketamine

preincisional:0.5mg/kgof ketamine bolus iv
intra- and postoperative until 48hr after surgery: ketamine 2mcg/kg/min,
continuous infusion
Interventions/Control_2 Control:Saline
preincisional: equinalent dose of saline
intra- and postoperative-48hr: equinalent dose of saline
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
10 years-old <=
Age-upper limit
19 years-old >=
Gender Male and Female
Key inclusion criteria ASA physical status 1-2 patients, aged 10-19 yr, scheduled to undergo posterior instrumentation for idiopathic scoliosis
Key exclusion criteria mental retardation,
history of opioid use within 3 months before surgery,
inability to self-administer morphine using patient-controlled analgesia pump,
younger than 6 years old,
renal dysfunction
asthama
congenital vertebra deformities
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shizuko Kosugi
Organization Keio University, School of Medicine
Division name Department of Anesthesiology
Zip code
Address 35, Shinanomchi, Shinjukuku, Tokyo
TEL 03-5363-3810
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shizuko Kosugi
Organization Keio University, School of Medicine
Division name Department of Anesthesiology
Zip code
Address
TEL
Homepage URL
Email shizuko.kosugi@gmail.com

Sponsor
Institute Keio University, School of Medicine
Department of Anesthesiology
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 04 Month 16 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
2013 Year 06 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 05 Month 01 Day
Date trial data considered complete
2015 Year 05 Month 01 Day
Date analysis concluded
2015 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 11 Day
Last modified on
2015 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012234

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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