Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery (NCT01638052) | Clinical Trial Compass
CompletedPhase 2
Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery
United States56 participantsStarted 2006-02
Plain-language summary
The investigators goal is to determine the efficacy and duration of analgesia with the addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of the great auricular nerve in children undergoing tympanomastoid surgery.
Who can participate
Age range
1 Year – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age 1-18 years
* tympanomastoid surgery (cochlear implant, mastoidectomy, cholesteatoma surgery)
* ASA I, II
* informed consent and assent obtained
Exclusion Criteria:
* allergic to local anesthestic
* taking chronic aspirin or Ibuprofen therapy
* ASA IV
* history of clinically important renal, hepatic, respiratory, cardiac, or neurological conditions
* Patients who have cardiovascular surgery other than an atrial septal defect or a ventricular septal defect, or who have undergone complete corrective intracardiac repair of congenital heart disease.
* Informed consent not obtained
* Patients expected to receive dexamethasone or ondansetron intra-operative
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average Observer-Rated Patient Pain Scores
Timeframe: 60 minutes
Trial details
NCT IDNCT01638052
SponsorAnn & Robert H Lurie Children's Hospital of Chicago