COMPLICATIONS RELATED CARBOXYHEMOGLOBIN LEVELS IN SECOND HAND SMOKING PEDIATRIC TONSILLECTOMY PATIENTS

This study is currently recruiting participants.
Verified September 2013 by Mustafa Kemal University
Sponsor:
Information provided by (Responsible Party):
Onur Koyuncu, Mustafa Kemal University
ClinicalTrials.gov Identifier:
NCT01942252
First received: September 10, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

The purpose of this study was to determine whether high carboxyhemoglobin level is a risk factor for postoperative adverse events in children exposured to carbon monoxide, especially enviromental tobacco smoke.


Condition Phase
Secondhand Smoking
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: COMPLICATIONS OF SECOND HAND SMOKING IN PEDIATRIC TONSILLECTOMY PATIENTS

Resource links provided by NLM:


Further study details as provided by Mustafa Kemal University:

Primary Outcome Measures:
  • Correlatin between carboxyhemoglobib levels of the second hand smoking children and postoperative complications and pain [ Time Frame: Postoperative 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Correlation between carboxyhemoglobin levels of the second hand smoking children and intraoperative bleeding volume [ Time Frame: Intraoperative period ] [ Designated as safety issue: Yes ]
    Any relation between carboxyhemoglobin and bleeding?


Other Outcome Measures:
  • Correlation between carboxyhemoglobin levels and pain of the second hand smoking children [ Time Frame: postoperative 24 hours ] [ Designated as safety issue: Yes ]
    Does second hand smoking affects pain?


Estimated Enrollment: 100
Study Start Date: August 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Also we want to measure bleeding volume and compare it with the carboxyhemoglobin levels.

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Inclusion Criteria:

-Patients 1-12 years old scheduled for adenotonsillectomy; written informed consent.

Criteria

Inclusion Criteria:

-Patients 1-12 years old scheduled for adenotonsillectomy; written informed consent.

Exclusion Criteria:

  • Active smokers, history of prematurity, bleeding disorders, hemolysis, severe pulmonary disease, home oxygen use, and inpatient hospitalisation≥24 h.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01942252

Contacts
Contact: onur koyuncu, Assist.Prof 905337744757 onurko@yahoo.com

Locations
Turkey
Mustafa Kemal University Recruiting
Hatay, Turkey, 31000
Contact: Onur Koyuncu, Asist.Prof    905337744757    onurko@yahoo.com   
Contact: Selim Turhanoglu, Prof.Dr    905325062988    adat63@gmail.com   
Principal Investigator: Selim Turhanoglu, Prof         
Sponsors and Collaborators
Mustafa Kemal University
Investigators
Study Director: ONUR KOYUNCU, ASSIST PROF Mustafa Kemal University
  More Information

Publications:
Responsible Party: Onur Koyuncu, Asist.Prof.Dr., Mustafa Kemal University
ClinicalTrials.gov Identifier: NCT01942252     History of Changes
Other Study ID Numbers: 207, Onur Koyuncu
Study First Received: September 10, 2013
Last Updated: September 10, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Mustafa Kemal University:
Secondhand smoking, pain, postoperative complications

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on April 17, 2014