The Effect of Adding Pain Relievers to Local Anesthesia B... | NCT01227200

Studies
The Effect of Adding Pain Relievers to Local Anesthesia Before Preforming Drainage in Peritonsillar Abscess

NCT01227200

Sponsor

HaEmek Medical Center, Israel

Status

Unknown status

Last Update Posted

Oct 25, 2010Estimated

Enrollment

32Estimated

Phase

Not Applicable

Conditions

Peritonsillar Abscess

Interventions

dypiron, tramadol

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Nov 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Oct 21, 2010

First Submission Date that Met QC Criteria

Oct 22, 2010

First Posted Date

Oct 25, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2010

Last Update Posted Date

Oct 25, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to find if adding oral pain relievers as DYPIRON and TRAMADOL in addition to the local anesthesia injection, can help reducing the pain intensity in patients who diagnosed as Suffering from peritonsillar abscess (PTA)and treated by incision and drainage .

Detailed Description

Control group: the patient will get local anesthesia injection with Lidocain. After 5 minutes- the DR will preform the incision and drainage of the abscess.

Then the patient will be asked by the vas score, the the pain intensity that he feels.

Intervention group:the patient will get dypiron 4 ml and tramadol 50 mg. after 40 minutes,the patient will get local anesthesia injection with Lidocain. After 5 minutes- the DR will preform the incision and drainage of the abscess.then the patient will be asked by the vas score, the the pain intensity that he feels.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dypiron, tramadol	Drug	dypiron 4 ML, tramadol 50 mg flashtab

Measure	Description	Time Frame
the vas scale		40 min after giving the oral drugs

Eligibility Module

Eligibility Criteria

Inclusion Criteria:patients with PTA in ages 18-65, who agreed to join the research -

Exclusion Criteria:cave to dypiron and/or tramadol, pregnant women, mental illness,soldiers.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
shani fisher, RN BA	Contact	046494311		SUNSHAN2@GMAIL.COM

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
otolaryngology department, HaEmek mc		Afula			Israel
Otolaryngology department, HaEmek MC

Condition Browse Module

MeSH Terms

ID	Term
D000039	Peritonsillar Abscess

Ancestor Terms

ID	Term
D014069	Tonsillitis
D010612	Pharyngitis
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014147	Tramadol

Ancestor Terms

ID	Term
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930

Browse Leaves

Not provided

Browse Branches

Not provided