Can Acetaminophen Given 1-2 Hours to Children Before Ear Tube Surgery Reduce Agitation After Anesthesia?
Condition: Emergence Agitation; Pain
MeSH terms: Psychomotor Agitation; Emergence Delirium
Intervention: Acetaminophen
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Minimum age: 6 Months
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: acetaminophen; emergence agitation; children; sevoflurane

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients' ≥ 6 months - 6 years

          -  Patients must meet criteria for American Society of Anesthesiologists (ASA) physical
             status I, II.

          -  Patients must not be pre-medicated.

          -  Parents must give written consent on the surgery day and be able to sign informed
             consent form on the surgery day.

          -  Undergoing BMT surgery only.

        Exclusion Criteria:

          -  Patients' <6 months and >6 years.

          -  Patients with known allergies to any of the medications used in this study.

          -  Patients with ASA status III & IV.

          -  Patients taking prescription pain medications prior to surgery.

          -  Patients taking medication that can cause drowsiness or alter mental status (eg.
             benzodiazepines, cough suppressants, diphenhydramine)

          -  Patients with significant history of psychiatric illness, neurologic disease (seizure
             disorder requiring medication therapy), and developmental delay.

          -  Patients have been pre-medicated.

          -  Patients undergoing other procedures that would prolong anesthetic exposure or
             confound post-operative pain.

          -  Intra-op complication that would require prolonged anesthetic exposure.

          -  If patient took acetaminophen prior to surgery and was not supposed to do so

          -  Patients that received ketorolac or additional analgesia during surgery.

          -  Patients that have liver disease.