Can Acetaminophen Given 1-2 Hours to Children Before Ear Tube Surgery Reduce Agitation After Anesthesia?
Public ClinicalTrials.gov record NCT01737593. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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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?
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01737593
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 108 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Months to 6 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2012
- Primary completion
- Mar 31, 2014
- Completion
- Mar 31, 2014
- Last update posted
- Oct 20, 2016
2012 – 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, Los Angeles Medical Center | Los Angeles | California | 90095 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01737593, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 20, 2016 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01737593 live on ClinicalTrials.gov.