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NCT01737593 · ClinicalTrials.gov registry record · Phase 4
Can Acetaminophen Given 1-2 Hours to Children Before Ear Tube Surgery Reduce Agitation After Anesthesia?
A Phase 4 study, sponsored by University of California, Los Angeles.
- Terminated
- Registry status
- Phase 4
- Development phase
- 108
- Enrollment target
NCT01737593 is a Phase 4 study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 108 participants.
The verdict
NCT01737593, a Phase 4 study, was terminated before completion, sponsored by University of California, Los Angeles.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 108 participants
- Enrollment target
Study 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.
Interventions
- DRUG Acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01737593
The ClinicalTrials.gov registry entry for NCT01737593 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Acetaminophen is the first listed.
NCT01737593 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01737593 about?
NCT01737593 is a clinical study titled "Can Acetaminophen Given 1-2 Hours to Children Before Ear Tube Surgery Reduce Agitation After 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 acet...
What is the current status of trial NCT01737593?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 108 participants. The study started on 2012-11. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01737593?
The interventions under investigation include: Acetaminophen (DRUG).
Who is sponsoring clinical trial NCT01737593?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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