COMPLICATIONS RELATED CARBOXYHEMOGLOBIN LEVELS IN SECOND HAND SMOKING PEDIATRIC TONSILLECTOMY PATIENTS

Secondhand Smoking Clinical Trial

Official title:

COMPLICATIONS OF SECOND HAND SMOKING IN PEDIATRIC TONSILLECTOMY PATIENTS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01942252
• Other study ID #: 207
• Secondary ID: Onur Koyuncu
• Status: Recruiting
• Phase: Phase 4
• First received: September 10, 2013
• Last updated: September 10, 2013
• Start date: August 2013
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Mustafa Kemal University
• Contact: onur koyuncu, Assist.Prof
• Phone: 905337744757
• Email: onurko[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Secondhand Smoking

Locations

Country	Name	City	State
Turkey	Mustafa Kemal University	Hatay

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Koop CE. Adverse anesthesia events in children exposed to environmental tobacco smoke: exposure to environmental tobacco smoke and the risk of adverse respiratory events in children receiving general anesthesia. Anesthesiology. 1998 May;88(5):1141-2. — View Citation

Skolnick ET, Vomvolakis MA, Buck KA, Mannino SF, Sun LS. Exposure to environmental tobacco smoke and the risk of adverse respiratory events in children receiving general anesthesia. Anesthesiology. 1998 May;88(5):1144-53. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between carboxyhemoglobin levels and pain of the second hand smoking children	Does second hand smoking affects pain?	postoperative 24 hours	Yes
Primary	Correlatin between carboxyhemoglobib levels of the second hand smoking children and postoperative complications and pain		Postoperative 24 hours	Yes
Secondary	Correlation between carboxyhemoglobin levels of the second hand smoking children and intraoperative bleeding volume	Any relation between carboxyhemoglobin and bleeding?	Intraoperative period	Yes