UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008412 |
|---|---|
| Receipt number | R000009896 |
| Scientific Title | Preemptive analgesia for tonsillectomy |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2015/01/12 23:01:22 |
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Basic information
Public title
Preemptive analgesia for tonsillectomy
Acronym
Preemptive analgesia for tonsillectomy
Scientific Title
Preemptive analgesia for tonsillectomy
Scientific Title:Acronym
Preemptive analgesia for tonsillectomy
Region
| Japan |
Condition
Condition
Oto-rhino-laryngology
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluatethe the effect of local infilatration anesthesia performed before surgery for analgesia after tonsillectomy in adults and children
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain after tonsillectomy
Key secondary outcomes
Dose of analgesics
Occurrence of postoperative nausea and vomiting and dose of antiemetics
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Use of analgesics in children
Interventions/Control_2
No use of analgesics in children
Interventions/Control_3
Use of analgesics in adolescence
Interventions/Control_4
No use of analgesics in adolescence
Interventions/Control_5
Use of analgesics in adults
Interventions/Control_6
No use of analgesics in adults
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 3 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing elective tonsillectomy under general anesthesia
Key exclusion criteria
Patients
1. with coagulation disorder
2. classified as American Society of Anesthesiologists Physical Status III, IV or V
3. with abcess in tonsil
4. undergoing adenoidectomy as well as tonsillectomy at the same time
5. receiving corticosteroids
6. possible difficulty in evaluating postoperative pain
7. with a history of abnormal reactions to general or local anesthetics
Target sample size
340
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryu Okutani |
Organization
Osaka City General Hospital and Children's Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-13-22, Miyakojimahondori, Miyakojma-ku, Osaka 534-0021, Japan
TEL
81-6-6929-1221
ryuokutani0909@ybb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryu Okutani |
Organization
Osaka City General Hospital and Children's Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-13-22, Miyakojimahondori, Miyakojma-ku, Osaka 534-0021, Japan
TEL
81-6-6929-1221
Homepage URL
ryu0909@kcat.zaq.ne.jp
Sponsor or person
Institute
Department of Anesthesiology, Osaka City General Hospital and Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Otolaryngology, Osaka City General Hospital and Children's Hospital
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
| 2012 | Year | 08 | Month | 01 | 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
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 12 | Day |
Last modified on
| 2015 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009896
