Pain Clinical Trial
Official title:
Can Acetaminophen PO Given 1-2 Hours Before Bilateral Myringotomy Tube (BMT) Placement Reduce Emergence Agitation (EA) in Children After General Sevoflurane Anesthesia?
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 6 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Emergence Agitation | The purpose of this study is to find out if acetaminophen given 60-120 minutes prior to emergence can decrease emergence agitation in patients undergoing BMT surgery. | Data will be collected at time points: Induction,Emergence(spontaneous extremity movement),and every 5 min after emergence until the patient is discharged. This is an average of 3 hours till discharge. | No |
Secondary | Pain | We will be using the Children's Hospital of Eastern Ontario Pain Scale to assess the child's pain level after surgery. | Data will be collected at the time points: Induction, Emergence (spontaneous extremity movement), and every 5 minutes after emergence until the patient is discharged. This is an average of 3 hours till discharge. | No |
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