UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Comparison of Analgesic Effect between Loxoprofen and Celecoxib and the Frequency of the Hemorrhage Following Tonsillectomy
Title of the study (Brief title)	A Comparison of Analgesic Effect between Loxoprofen and Celecoxib and the Frequency of the Hemorrhage Following Tonsillectomy
Region	Japan

Condition
Condition	chronic tonsillitis,peritonsillar abscess,sleep apnea syndrome
Classification by specialty	Oto-rhino-laryngology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For a pain-killer to give after palatine tonsil enucleation, conventional NSAIDs is often chosen. However, because NSAIDs inhibits both of COX-1 and COX-2 nonselectively, I control the platelet aggregation action that is physiological action of COX-1 at the same time, and the possibility that it becomes the factor of the bleeding after art has it pointed out. In contrast, it is said that there are few side effects such as the bleeding tendency because NSAIDs having selective COX-2 inhibition does not control platelet aggregation action. Therefore I examine painkilling effects enough again whether you reduce frequency of the bleeding after art more when it chooses conventional NSAIDs (loxoprofen) to choose selective COX-2 inhibitor (celecoxib) as a pain-killer this time whether you are provided safely.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	On a patient background, the total dosage days of the pain-killer, the self-evaluation (I include VAS scale) for the painkilling effect, a ratio (rescue dosage rate), the days of the case receiving the rescue, a last dosage day, I did it with a side effect after presence of the bleeding and degree, art after a side effect, a hospitalized total eating rate, art at time of the bleeding.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is 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	Only as for the first time, I gave 200 mg of once after dinner after the second at 400 mg with celecoxib twice a day for the celecoxib group in morning after the next day five hours after an operation.
Interventions/Control_2	I gave 60 mg of loxoprofen after every meal with 60 mg of once after the second three times a day for the loxoprofen group five hours after an operation only in the first time.
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	15 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients such as tonsillitis chronic in 15 years old or more that enforced both sides palatine tonsil enucleation on January 1, 2017 by December 31, 2017, almond peritonsillar abscess, sleep apnea syndrome.
Key exclusion criteria	The Patient of allergy to celecoxib and bronchial asthma is excluded
Target sample size	30

Research contact person
Name of lead principal investigator	Makoto Sugiura
Organization	Tosei General Hospital
Division name	Otolaryngology
Address	160, Nishioiwakecho, Seto-shi, Aichi
TEL	0561825101
Email	masahirof@tosei.or.jp

Public contact
Name of contact person	Masahiro Fukushima
Organization	Tosei General Hospital
Division name	Otolaryngology
Address	160, Nishioiwakecho, Seto-shi, Aichi
TEL	0561825101
Homepage URL
Email	masahirof@tosei.or.jp

Sponsor
Institute	Tosei General Hospital
Institute
Department

Funding Source
Organization	nothing
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	2016 Year 12 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 12 Month 01 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 11 Day
Last modified on	2017 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028046