Can Acetaminophen Given 1-2 Hours to Children Before Ear Tube Surgery Reduce Agitation After Anesthesia?
Status:
Terminated
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
Emergence agitation (EA) occurs in up to 67% of pediatric patients after anesthesia for
bilateral myringotomy tubes (BMT, "ear tubes"). The goal of this study is to find out whether
acetaminophen given well before surgery can decrease pain and therefore, decrease emergence
agitation better than acetaminophen given shortly before or during surgery. EA can be
dangerous for the patient because it may be hard to monitor their vital signs during an
important phase of recovery, they may injure themselves, may require the presence of extra
staff, and it can be very distressing to the parents. Causes of EA are not well understood,
but it can be worsened by pain. 70% of patients undergoing BMT experience pain that needs
treatment. Intranasal fentanyl, a strong analgesic, has been shown to decrease EA, but often
ends up in dose-dependent nausea and vomiting. In previous studies and in common practice,
acetaminophen is given either 30 minutes before induction of anesthesia or immediately after
induction. The peak analgesic effect of acetaminophen is 60-120 minutes. Since the procedure
is generally completed in 5-10 minutes, the therapeutic effect of acetaminophen may not be
present upon emergence from anesthesia.
The purpose of this study is to find out if acetaminophen given 60-120 minutes prior to
emergence can decrease EA in patients undergoing BMT. Patients would be randomized to one of
three groups: Control will receive acetaminophen rectally while under anesthesia (standard
practice), Group 1 will receive acetaminophen 10 mg/kg at 60-120 minutes prior to surgery,
Group 2 will receive acetaminophen 20 mg/kg at 60-120 minutes prior to surgery. All groups
would also receive a dose of intranasal fentanyl during the surgery, which is standard
practice. Patients would be observed in the recovery room at various time points for evidence
of EA and pain.