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NCT02383004 · ClinicalTrials.gov registry record · NA
Acupuncture for the Prevention of Emergence Delirium in Children Undergoing Myringotomy Tube Placement
A NA study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT02383004 is a NA study that has completed, run by Oregon Health and Science University. The registered enrollment target is 100 participants.
The verdict
NCT02383004, a NA study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
Myringotomy tube placement is one of the most commonly performed operations in children. Emergence delirium after such procedures is common. During emergence delirium children can become both a danger to themselves and others around them, including family members and hospital staff. The primary objective of this study is to determine if acupuncture, when used in combination with standard anesthetic management, decreases the incidence of emergence delirium in pediatric patients following myringotomy tube placement. Patients with and without premedication of midazolam will be included. A secondary objective of this study is to determine our institution's actual incidence of emergence delirium for this operation using a validated scale, the Pediatric Anesthesia Emergence Delirium (PAED) scale. We will also compare rates of emergence delirium in patients that received a premedication of midazolam versus (V) those that did not (NV). This is a randomized double-blinded trial. We will enroll 100 children aged 1-6 years old. Premedication with midazolam will be decided by the anesthesiologist. If needed, the patient will receive a standard does of oral midazolam plus acetaminophen (V). If the patient does not require premedication with midazolam, oral acetaminophen will be given alone (NV). Patients will then be randomized to receive either acupuncture with standard general anesthesia care (A) or to receive standard anesthetic care alone (S). Patients, their family members and recovery registered nurses (RNs) will not know if acupuncture was performed. Intraoperative anesthetic techniques will be standardized and include inhaled inductions with nitrous oxide and sevoflurane. Anesthesia maintenance will be inhaled sevoflurane and the usual pain medication ketorolac will be given intramuscularly prior to emergence. Acupuncture needles will be placed after anesthesia induction and removed prior to leaving the operating room. A total of 4 needles will be placed, one in each
Interventions
- OTHER Acupuncture
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2015-02 |
| Est. Completion | 2016-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02383004
The ClinicalTrials.gov registry entry for NCT02383004 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Acupuncture is the first listed.
NCT02383004 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02383004 about?
NCT02383004 is a clinical study titled "Acupuncture for the Prevention of Emergence Delirium in Children Undergoing Myringotomy Tube Placement". Myringotomy tube placement is one of the most commonly performed operations in children. Emergence delirium after such procedures is common. During emergence delirium children can become both a danger to themselves and others around them, including family members and hospital staff. The primary obj...
What is the current status of trial NCT02383004?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2015-02. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02383004?
The interventions under investigation include: Acupuncture (OTHER).
Who is sponsoring clinical trial NCT02383004?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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