Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty

NACompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

September 29, 2016

Study Completion Date

September 29, 2016

Conditions
Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis
Interventions
DEVICE

Acclarent Relieva Balloon Sinuplasty

"A rigid nasal endoscopy will be performed. After decongesting with oxymetazoline hydrochloride, the balloon catheter device will be inserted and the wire/balloon will be threaded through the maxillary sinus ostia. Confirmation of location will be per manufacturer's recommendation with either fluoroscopy or illumination. Following confirmation, the balloon will be dilated under visualization per manufacture's recommendation. After the visualization of the dilated ostia, cultures for aerobic/anerobic examination will be taken and irrigation with 10ml of isotonic sodium chloride will be performed.~Adenoidectomy will be performed using either the microdebrider or suction electrocautery in the usual manner."

PROCEDURE

Adenoidectomy + Maxillary Sinus Irrigation

"A rigid nasal endoscopy will be performed. After decongesting with oxymetazoline hydrochloride, the maxillary sinuses will be entered via middle meati punctures using either a sterile spinal needle or a curved suction. Sinus contents will be aspirated and sent for aerobic/anaerobic cultures. Irrigation with 10ml of isotonic sodium chloride will be performed. If no material is aspirated initially, the sinus contents will be re-aspirated after irrigation and sent for aerobic/anaerobic cultures.~Adenoidectomy will be performed using either the microdebrider or suction electrocautery in the usual manner.~After adequate hemostasis, the patient will be awakened and brought to the recovery room. Depending on the recovery, the child will either be admitted or discharged home."

Trial Locations (1)

60201

NorthShore University HealthSystem, Evanston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Endeavor Health

OTHER