The Effect of Adding Pain Relievers to Local Anesthesia Before Preforming Drainage in Peritonsillar Abscess (pta)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by HaEmek Medical Center, Israel.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01227200
First received: October 21, 2010
Last updated: October 22, 2010
Last verified: October 2010
  Purpose

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 .


Condition Intervention
Peritonsillar Abscess
Drug: dypiron, tramadol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Efficiency of DYPIRON and TRAMADOL in Addition to Local Anesthesia Prior to Incision and Drainage Procedure in Peritonsillar Abscess

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • the vas scale [ Time Frame: 40 min after giving the oral drugs ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: November 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: dypiron, tramadol
    dypiron 4 ML, tramadol 50 mg flashtab
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227200

Contacts
Contact: shani fisher, RN BA 046494311 SUNSHAN2@GMAIL.COM

Locations
Israel
otolaryngology department, HaEmek mc Active, not recruiting
Afula, Israel
Otolaryngology department, HaEmek MC Not yet recruiting
Afula, Israel
Principal Investigator: Dror Ashkenazy, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

No publications provided

Responsible Party: orolaryngology department, HaEmek MC
ClinicalTrials.gov Identifier: NCT01227200     History of Changes
Other Study ID Numbers: emc100061ctil
Study First Received: October 21, 2010
Last Updated: October 22, 2010
Health Authority: Israel: Clalit Health Services

Additional relevant MeSH terms:
Pharyngitis
Abscess
Peritonsillar Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Tonsillitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Anesthetics
Tramadol
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 23, 2014