Childhood Adenotonsillectomy Trial

7.5.3 Informed Consent

Informed consent will be obtained from all patients listing possible complications of surgery (including but not limited to: damage to teeth, trauma or burns to soft tissue, bleeding, infection, changes in voice or swallowing, regrowth of tonsils and adenoids, airway obstruction, dehydration, scarring, stenosis, worsening of symptoms, need for further surgery and death) as well as possible complications from general anesthesia.

Participants and parent (s) will be informed verbally and in writing, at the time of informed consent and throughout the trial, that any surgical complications, emergency room visits, hospitalization, surgical procedures or changes in health status must be reported to the project coordinator. Emergency contact phone number and pager will be listed on first page of the consent form and pointed out to the participant’s guardian when they receive a copy of signed informed consent.